https://www.smartmdr.com/notcias daily 0.75 2026-04-01 https://www.smartmdr.com/notcias/european-commission-expands-list-of-class-iib-implantable-devices-exempt-from-individual-technical-documentation-assessment monthly 0.5 2026-04-01 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/34fc2870-5f58-495c-93f2-f9a3e3092de5/ALT%2BEUROPEAN%2BCOMISSION%2BCLASS%2BIIB.png Notícias - European Commission Expands List of Class IIb Implantable Devices Exempt from Individual Technical Documentation Assessment - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/portuguese-medtech-market-overview-of-opportunities-and-requirements-for-manufacturers monthly 0.5 2026-03-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/d6b7469e-d1b1-4ce6-bb14-dc49082aa5d3/ALT%2BAPORMED%2BPORTUGUESE%2BMARKET%2BSME.png Notícias - Portuguese MedTech Market: Overview of Opportunities and Requirements 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https://www.smartmdr.com/notcias/european-reference-networks-continue-to-expand-what-it-means-for-medical-device-manufacturers monthly 0.5 2026-03-20 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/f4556793-053a-447b-ac44-49a283e00106/ALT%2BEUROPEAN%2BREFERENCE%2BNETWORKS%2BMEDICAL%2BDEVICES.png Notícias - European Reference Networks Continue to Expand: What It Means for Medical Device Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publishes-updated-guidance-on-pyrogen-and-endotoxins-testing monthly 0.5 2026-03-20 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c1685448-b941-45c9-87c5-e1a90f0b2688/ALT%2BFDA%2BGUIDANCE%2BPYROGEN%2BENDOTOXINS%2BTESTING%2BQ%2BA.png Notícias - FDA Publishes Updated Guidance on Pyrogen and Endotoxins Testing - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-issues-final-guidance-on-medical-devices-with-indications-associated-with-weight-loss monthly 0.5 2026-03-13 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/9947885d-ef58-4ec7-8116-4ce41404d2f4/ALT%2BFDA%2BMEDICAL%2BDEVICES%2BINDICATIONS%2BWEIGHT%2BLOSS.png Notícias - FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-updates-formal-requirements-guidance-version-200-now-in-force monthly 0.5 2026-03-06 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/76fbd731-4e1d-413c-91f6-c6249af78d6d/ALT%2BSWISSMEDIC%2BGUIDANCE%2BDOCUMENT.png Notícias - Swissmedic Updates “Formal Requirements” Guidance – Version 20.0 Now in Force - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-updates-swissdamed-udi-data-dictionary monthly 0.5 2026-03-05 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/79f48366-6043-4bb3-a4c2-92fcf496c867/ALT%2BSWISSMEDIC%2BUDI%2BDATA%2BUPDATE.png Notícias - Swissmedic Updates swissdamed UDI Data Dictionary - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/team-nb-raises-concerns-over-proposed-mdr-and-ivdr-revision monthly 0.5 2026-03-05 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/d71248f7-8f36-42f2-bc1f-b6d43cb50f2f/ALT%2BTEAM%2BNB%2BPOSITION%2BPAPER%2BMDR%2BIVDR%2BREVISION%2BIMPACT%2BSECTOR.png Notícias - Team-NB Raises Concerns Over Proposed MDR and IVDR Revision - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-publishes-updated-guidance-on-the-regulation-of-software-based-medical-devices-key-considerations-for-manufacturers monthly 0.5 2026-02-28 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/2bcaff75-e7f6-4b56-be4b-1b4460beb962/ALT%2BTGA%2BUNDERSTANDING%2BREGULATE%2BSOFTWARE%2BBASED%2BMEDICAL%2BDEVICES.png Notícias - TGA Publishes Updated Guidance on the Regulation of Software-Based Medical Devices – Key Considerations for Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/imdrf-publishes-final-guidance-on-the-selection-of-adverse-event-terminology monthly 0.5 2026-02-28 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c9786a2e-81c4-4fe2-a421-7fd3958698cf/ALT%2BIMDRF%2BCONSIDERATIONS%2BSELECTION%2BADVERSE%2BEVENT%2BTERMINOLOGY.png Notícias - IMDRF Publishes Final Guidance on the Selection of Adverse Event Terminology - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/imdrf-publishes-2026-playbook-for-medical-device-regulatory-reliance-programs monthly 0.5 2026-02-28 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/d6433685-ba07-48cf-9fb0-c7a2d52c3c10/ALT%2BIMDRF%2BPLAYBOOK%2BMEDICAL%2BDEVICE%2BREGULATORY%2BRELIANCE%2BPROGRAMS.png Notícias - IMDRF Publishes 2026 Playbook for Medical Device Regulatory Reliance Programs - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-updates-prac-guidance-what-sponsors-and-manufacturers-need-to-know-in-2026 monthly 0.5 2026-02-27 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b50f4e13-4b82-4afb-a752-5e3bfe5b5c27/ALT%2BTGA%2BPROCEDURE%2BRECALLS%2BPRAC.png Notícias - TGA Updates PRAC Guidance: What Sponsors and Manufacturers Need to Know in 2026 - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-publishes-swissdamed-machine-to-machine-rest-api-documentation-version-10 monthly 0.5 2026-02-27 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/9af87526-0641-4665-9319-30ab9b8362cd/ALT%2BSWISSMEDIC%2BTECHNICA%2BDOCUMENT%2BMACHINE%2BREST%2BAPI.png Notícias - Swissmedic Publishes swissdamed Machine-to-Machine REST API Documentation (Version 1.0) - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mhra-updates-guidance-on-regulation-of-medical-devices-in-northern-ireland monthly 0.5 2026-02-27 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/2579f996-bf1e-4d5a-85ef-a529dddf35bd/ALT%2BGOV%2BUK%2BREGULATION%2BMEDICAL%2BDEVICES%2BNORTHERN%2BIRELAND%2BMHRA.png Notícias - MHRA Updates Guidance on Regulation of Medical Devices in 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o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-updates-recognized-biocompatibility-standards-recognition-list-no-065 monthly 0.5 2026-02-25 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/3926941d-a6fd-4540-a4f4-43d9e3a7b4b7/ALT%2BFDA%2BLIST%2BRECOGNIZED%2BSTANDARDS%2BBIOCOMPATIBILITY.png Notícias - FDA Updates Recognized Biocompatibility Standards – Recognition List No. 065 - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/teamnb-publishes-new-guidance-on-demonstrating-safety-and-performance-for-reagent-devices-used-in-combination monthly 0.5 2026-02-25 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/1029769c-38e2-4c20-b91b-8554df8c709a/ALT%2BTEAM%2BNB%2BPOSITION%2BPAPER%2BSAFETY%2BPERFORMANCE%2BCOMBINATORIAL%2BUSE.png Notícias - Team-NB Publishes New Position Paper on Safety and Performance of 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espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/anvisa-publishes-draft-normative-instruction-on-udi-data-transmission-and-siud-management monthly 0.5 2026-02-13 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/115671d5-4999-4462-9495-aa2294d043ca/ALT%2BANVISA%2BTEMPLATE.png Notícias - ANVISA Publishes Draft Normative Instruction on UDI Data Transmission and SIUD Management - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publishes-draft-ich-e22-guideline-on-patient-preference-studies-for-public-consultation monthly 0.5 2026-02-10 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/15411e2d-04a6-4355-a404-e0e4a824b2ac/ALT%2BFDA%2BGENERAL%2BCONSIDERATIONS%2BPATIENT%2BPREFERENCE%2BSTUDIES.png Notícias - FDA Publishes Draft ICH E22 Guideline on Patient Preference Studies for Public Consultation - 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19.0 Applicable from February 2026 - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-issues-updated-guidance-on-computer-software-assurance-for-production-and-qms-software monthly 0.5 2026-02-07 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c4fb6999-d688-4407-a587-672b45761052/ALT%2BFDA%2BCOMPUTER%2BSOFTWARE%2BASSURANCE%2BPRODUCTION%2BQUALITY%2BMANAGEMENT%2BSYSTEM%2BSOFTWARE.png Notícias - FDA Issues Updated Guidance on Computer Software Assurance for Production and QMS Software - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/eudamed-production-v2220-what-manufacturers-need-to-know monthly 0.5 2026-02-07 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/4825c80e-774c-4e41-bda8-0f495b81c53c/ALT%2BEUDAMED%2BRELEASE%2BNOTES.png Notícias - EUDAMED Production v2.22.0: What 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https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/6b34a78a-8dfd-4a22-ad0a-9266f4125729/ALT%2BEURO%2BEAN%2BINDIVIDUALS%2BEU-US.png Notícias - EU-U.S. Data Privacy Framework Updated: What It Means for Medical Device Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/medtech-europe-proposes-targeted-reforms-to-mdr-and-ivdr-strategic-input-for-2026-regulatory-revisions monthly 0.5 2026-01-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/35856ec5-341f-4e16-b324-44216c03d172/ALT%2BMEDTECH%2BEUROPE%2BCALL%2BFOR%2BEVIDENCE.png Notícias - MedTech Europe Proposes Targeted Reforms to MDR and IVDR – Strategic Input for 2026 Regulatory Revisions - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/new-mhra-summary-uk-conformity-assessment-routes-for-all-device-classes monthly 0.5 2026-01-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/9e4d6d7d-210f-43f2-9daf-7bdd96a91f4c/ALT%2BMHRA%2BUK%2BMDR%2BCLASSES%2BMEDICAL%2BDEVICES.png Notícias - New MHRA Summary: UK Conformity Assessment Routes for All Device Classes - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publishes-updated-guidance-on-clinical-decision-support-software monthly 0.5 2026-02-04 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/7743bbef-cd92-4892-a776-f7e19dce620d/ALT%2BFDA%2BCLINICAL%2BDECISION%2BSUPPORT%2BSOFTWARE.png Notícias - FDA Publishes Updated Guidance on Clinical Decision Support Software - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/australia-updates-guidance-on-export-certificates-for-medical-devices-what-eu-manufacturers-need-to-know monthly 0.5 2026-01-27 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ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026 - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-updates-guidance-on-clinical-decision-support-cds-software-for-healthcare-professionals monthly 0.5 2026-01-14 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c584dddb-4988-40c3-b267-48949fc17c84/ALT%2BFDA%2BGUIDANCE%2BCLINICAL%2BDECISION%2BSUPPORT%2BSOFTWARE.png Notícias - FDA Updates Guidance on Clinical Decision Support (CDS) Software for Healthcare Professionals - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/new-fda-guidance-clarifies-policy-for-low-risk-general-wellness-devices monthly 0.5 2026-01-14 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monthly 0.5 2026-01-07 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/86047ded-13b8-40f9-81ea-8a6acb9a0ccb/ALT%2BSMART%2BMDR%2BLIMITED%2BOFFER.png Notícias - Kickstart your 2026 Regulatory Strategy with Smart MDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/comece-2026-com-o-p-direito-no-mercado-europeu- monthly 0.5 2026-01-07 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/f309204c-a29d-4824-bbb4-48bc7cd63170/ALT%2BSMART%2BMDR%2BOFERTA%2BLIMITADA.png Notícias - Comece 2026 com o pé direito no Mercado Europeu! - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/okxeiaeovrgp88mfzdjdenb1a9semc monthly 0.5 2025-12-23 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https://www.smartmdr.com/notcias/anvisa-updates-manual-for-medical-device-registration-in-brazil monthly 0.5 2025-12-22 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/3b8fbd64-12bb-4d15-9d7e-6af0f63b8d59/ALT%2BANVISA%2BREGISTRATION%2BMANUAL%2BHEATH%2BMATERIALS.png Notícias - ANVISA Updates Manual for Medical Device Registration in Brazil - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mdcg-2025-10-strengthened-expectations-for-pms-systems-under-mdr-and-ivdr monthly 0.5 2025-12-22 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/011abb02-885b-40c9-8732-eec934323a7b/ALT%2BMDCG%2BGUIDANCE%2BPMS%2BMEDICAL%2BDEVICES%2BIVD.png Notícias - MDCG 2025-10: Strengthened expectations for PMS systems under MDR and IVDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. 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Investigations for Medical Devices: Key Implications for Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/european-commission-launches-the-digital-fitness-check-implications-for-medical-device-manufacturers monthly 0.5 2025-11-24 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/0fe0e11f-10d8-44f8-a2ca-18e06aeee9d7/ALT%2BEUROPEAN%2BCOMISSION%2BCALL%2BEVIDENCE%2BDIGITAL%2BFITNESS%2BCHECK.png Notícias - European Commission Launches the Digital Fitness Check: Implications for Medical Device Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-updates-guidance-on-essential-principles-for-medical-device-safety-and-performance monthly 0.5 2025-11-21 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/cf134018-e6c0-49a8-b7d3-077619408515/ALT%2BAUSTRALIAN%2BGOVERNMENT%2BMEDICAL%2BDEVICE%2BSAFETY%2BPERFORMANCE.png Notícias - TGA Updates Guidance on Essential Principles for Medical Device Safety and Performance - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-updates-guidance-on-export-certificates-key-implications-for-medical-device-manufacturers monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b8e2a94b-d262-4cff-a170-f5bbf8a9d039/ALT%2BSWISS%2BMEDICA%2BGUIDANCE%2BDOCUMENT%2BEXPORT%2BCERTIFICATES.png Notícias - Swissmedic Updates Guidance on Export Certificates: Key Implications for Medical Device Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/health-canada-launches-phase-ii-of-the-mdel-modernization-framework-key-impacts-for-manufacturers monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/bd30622c-f0b2-41d3-a638-bf386770a8a3/ALT%2BCANADA%2BREGULATIONS%2BAMENDING%2BMEDICAL%2BDEVICES%2BREGULATIONS%2BEstablishment%2BLicences.png Notícias - Health Canada Launches Phase II of the MDEL Modernization Framework: Key Impacts for Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publishes-final-guidance-on-computer-software-assurance-key-implications-for-manufacturers monthly 0.5 2025-11-14 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/9e7fdefc-8a86-479f-afed-60a3d451da00/ALT%2BFDA%2BCOMPUTER%2BSOFTWARE%2BASSURANCE%2BQUALITY%2BSYSTEM%2BSOFTWARE.png Notícias - FDA Publishes Final Guidance on Computer Software Assurance: Key Implications for Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-issues-updated-scientific-recommendations-for-biosimilars-what-manufacturers-need-to-know monthly 0.5 2025-11-14 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/2eef58c9-c640-4311-bdb5-72212c84460d/ALT%2BFDA%2BCIENTIFIC%2BBIOSIMILARITY%2BUPDATED.png Notícias - FDA Issues Updated Scientific Recommendations for Biosimilars: What Manufacturers Need to Know - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mdcg-2025-8-new-guidance-on-master-udi-di-implementation-for-spectacles-and-highly-individualised-devices monthly 0.5 2025-11-14 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/e7e9737f-d6b3-4b99-a8e1-36598feabdc5/ALT%2BMDCG%2B2025%2B8%2BGUIDANCE%2BIMPLEMENTATION%2BMASTER%2BUDI%2BDI.png Notícias - MDCG 2025-8: 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https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/23c8580a-7c59-4b92-bd4e-5131c9b5838c/ALT%2BSWISS%2BMEDIC%2BGUIDANCE%2BDOCUMENT%2BPSUR%2BSIGNAL%2BMANAGMENT.png Notícias - Swissmedic Reinforces Signal Management and PSUR Requirements for Veterinary Medicinal Products - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-draft-guidance-aligns-qms-requirements-with-iso-13485-what-it-means-for-medical-device-manufacturers monthly 0.5 2025-10-28 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/e84cf558-fdc2-4980-8c62-6a141c184656/ALT%2BFDA%2BQUALITY%2BMANAGEMENT%2BSYSTEM%2BINFORMATION%2BPREMARKET%2BSUBMISSION%2BREVIEWS.png Notícias - FDA Draft Guidance Aligns QMS Requirements with ISO 13485: What It Means for Medical Device Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/new-anvisa-manual-guides-medical-device-and-ivd-manufacturers-through-brazils-regulatory-pathway monthly 0.5 2025-10-23 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b7b31ceb-d049-4af6-b8af-f3d367bbf424/ALT%2BANVISA%2BREGULATION%2BSOFTWARE%2BMEDICAL%2BDEVICE%2BEQUIPMENT.png Notícias - New ANVISA Manual Guides Medical Device and IVD Manufacturers Through Brazil’s Regulatory Pathway - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-issues-strategic-guidance-on-decentralized-clinical-trials-a-turning-point-for-medical-device-and-ivd-manufacturers monthly 0.5 2025-10-22 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/1c10c58e-0ba2-42a6-b874-8973130f3e38/ALT%2BFDA%2BCONDUNCTING%2BCLINICAL%C2%B4TRIALS%2BDECENTRALIZED%2BELEMENTS.png Notícias - FDA Issues Strategic Guidance on Decentralized Clinical Trials – A Turning Point for 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regulação de IA para dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/novas-normas-internacionais-em-desenvolvimento-para-o-setor-dos-dispositivos-mdicos monthly 0.5 2025-10-20 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b2381416-1985-46a7-9bf8-e80ab1b52706/ALT%2BISO%2BMEDICAL%2BDEVICES%2BSTANDARD.png Notícias - Novas normas internacionais em desenvolvimento para o setor dos dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/eudamed-v2180-nova-atualizao-traz-melhorias-importantes-para-fabricantes-e-distribuidores-de-dispositivos-mdicos monthly 0.5 2025-10-17 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b8dfa3ef-0983-4f28-a8e3-ae5764463790/ALT%2BEUROPEAN%2BCOMISSION%2BEUDAMED%2BRELEASE%2BNOTES.png Notícias - EUDAMED v2.18.0: Nova Atualização Traz Melhorias Importantes para Fabricantes e Distribuidores de Dispositivos Médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/notified-bodies-apelam-comisso-europeia-por-um-quadro-mais-eficiente-e-harmonizado-no-contexto-do-ai-act monthly 0.5 2025-10-19 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/4a50b6c2-217f-4493-806f-ff771a071b2e/ALT%2BNBs%2BMDR%2BIVDR%2BCALL%2BFOR%2BEVIDENCE%2BDG%2BCONNECT.png Notícias - Notified Bodies apelam à Comissão Europeia por um quadro mais eficiente e harmonizado no contexto do AI Act - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-lana-novo-portal-eletrnico-para-comunicaes-de-segurana monthly 0.5 2025-10-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/de8da494-d88a-4ce5-b187-42c7a327e29e/ALT%2BSWISSMEDIC%2BInformation%2BSheet%2BEGOV%2BPORTAL%2BSAFETY%2BCOMMUNICATION%2BSERVICE.png Notícias - Swissmedic lança novo portal eletrónico para comunicações de segurança - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-novas-especificaes-tcnicas-para-submisso-de-dados-clnicos-em-ensaios-sobre-leucemias-agudas monthly 0.5 2025-10-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/f7a6778c-08a3-459d-b066-5de53bf892d3/ALT%2BFDA%2BTECHNICAL%2BSPECIFICATIONS%2BDOCUMENT%2BGUIDANCE%2BINDUSTRY.png Notícias - FDA publica novas especificações técnicas para submissão de dados clínicos em ensaios sobre leucemias agudas - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/comisso-europeia-e-edpb-publicam-orientaes-conjuntas-sobre-a-articulao-entre-o-dma-e-o-rgpd monthly 0.5 2025-10-13 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/fab34b33-d85d-4990-aa66-5475a6e541d8/ALT%2BEUROPEAN%2BCOMISSION%2BEDPB%2BGENERAL%2BDATA%2BPROTECTION%2BREGULATION.png Notícias - Comissão Europeia e EDPB publicam orientações conjuntas sobre a articulação entre o DMA e o RGPD - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mhra-atualiza-orientaes-sobre-investigaes-clnicas-de-dispositivos-mdicos-1 monthly 0.5 2025-10-09 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/0725347f-07bf-452b-abfc-d276519ad5cc/ALT%2BMHRA%2BCLINICAL%2BINVESTIGATIONS%2BMEDICAL%2BDEVICES%2BGUIDANCE%2BMANUFACTURES.png Notícias - MHRA atualiza orientações sobre investigações clínicas de dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/brasil-regulamenta-o-sistema-nacional-de-tica-em-pesquisa-com-seres-humanos monthly 0.5 2025-10-09 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b8616344-a36f-46cf-99d9-44acb41972f7/ALT%2BDIARIO%2BOFICIAL%2BBRASIL%2BPESQUISA%2BCLINICA.png Notícias - Brasil regulamenta o Sistema Nacional de Ética em Pesquisa com Seres Humanos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-atualiza-orientaes-sobre-software-de-apoio-deciso-clnica monthly 0.5 2025-10-07 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/5c557c9b-2652-4f4a-a044-40d882015abb/ALT%2BTGA%2BUNDERSTANDING%2BCLINICAL%2BDECISION%2BSUPPORT%2BSOFTWARE.png Notícias - TGA atualiza orientações sobre software de apoio à decisão clínica - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-publica-lista-de-verificao-para-implementao-do-sistema-udi-na-austrlia monthly 0.5 2025-10-07 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/fcb2e471-fbe4-4a08-b9a5-72d2b73d2a29/ALT%2BAUSTRALIAN%2BUNIQUE%2BDEVICE%2BIDENTIFICATION%2BUDI.png Notícias - TGA publica lista de verificação para implementação do sistema UDI na Austrália - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mhra-atualiza-orientaes-sobre-investigaes-clnicas-de-dispositivos-mdicos monthly 0.5 2025-10-08 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/3b45c5ed-a379-4b95-9c47-c87bd7d5c7d5/ALT%2BUK%2BCLINICAL%2BINVESTIGATIONS%2BMEDICAL%2BDEVICES.png Notícias - MHRA atualiza orientações sobre investigações clínicas de dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/cibersegurana-em-dispositivos-mdicos-guia-de-conformidade-da-tga monthly 0.5 2025-10-03 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/d10cdae9-d8a7-4844-9437-f77f8cf40755/ALT%2BTGA%2BMEDICAL%2BDEVICES%2BCYBER%2BSECURITY%2BREQUIREMENTS.png Notícias - Cibersegurança em Dispositivos Médicos: Guia de Conformidade da TGA - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-orientao-sobre-computer-software-assurance-para-sistemas-de-produo-e-qualidade monthly 0.5 2025-09-24 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/cc5b53cd-014c-48e6-882d-4abec4afae4c/ALT%2BCOMPUTER%2BSOFTWARE%2BASSURANCE%2BPRODUCTION%2BQUALITY%2BSYSTEM%2BFDA.png Notícias - FDA publica orientação sobre Computer Software Assurance para sistemas de produção e qualidade - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/exportao-de-medicamentos-a-partir-da-austrlia-guia-atualizado-da-tga monthly 0.5 2025-09-24 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c94b067b-9035-45b3-a2fc-af0508a78b54/ALT%2BEXPORTING%2BMEDICINES%2BAUSTRALIA%2BTGA.png Notícias - Exportação de Medicamentos a Partir da Austrália: Guia Atualizado da TGA - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-orientao-sobre-polticas-de-aplicao-para-testes-de-diagnstico-in-vitro-durante-emergncias-de-sade-pblica monthly 0.5 2025-09-24 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/70674b93-9c4b-4b27-9bbc-a9a891c69bfc/ALT%2BIVD%2BTESTS%2BFDA.png Notícias - FDA publica orientação sobre políticas de aplicação para testes de diagnóstico in vitro durante emergências de saúde pública - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/nova-regulamentao-da-comisso-europeia-simplifica-atribuio-de-udi-a-armaes-lentes-oftlmicas-e-culos-de-leitura-pr-montados monthly 0.5 2025-09-25 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/64ee6928-36b8-4e48-9860-a1155167d450/ALT%2BCOMISSION%2BDELEGATED%2BREGULATION%2BMDR.png Notícias - Nova regulamentação da Comissão Europeia simplifica atribuição de UDI a armações, lentes oftálmicas e óculos de leitura pré-montados - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/comisso-europeia-lana-consulta-para-reviso-direcionada-do-mdr-e-ivdr monthly 0.5 2025-09-22 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/cfd1e65d-344b-4c31-af22-a1f9e7e5e310/ALT%2BEUROPEAN%2BCOMISSION%2BCALL%2BFOR%2BEVIDENCE.png Notícias - Comissão Europeia lança consulta para revisão direcionada do MDR e IVDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/team-nb-publica-orientao-de-melhores-prticas-para-submisso-de-documentao-tcnica-sob-o-ivdr monthly 0.5 2025-09-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/a3cbcf3f-568e-41c3-aafb-511511eb1ca2/ALT%2BTEAM%2BNB%2BPOSITION%2BPAPER%2BMDR.png Notícias - Team-NB publica orientação de melhores práticas para submissão de documentação técnica sob o IVDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/nova-verso-do-manual-de-fronteira-e-classificao-de-dispositivos-mdicos-publicada-pela-unio-europeia monthly 0.5 2025-09-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/99967e04-462c-494b-9dcd-cd4d064951b8/ALT%2BMANUAL%2BBORDERLINE%2BMEDICAL%2BDEVICES%2BMDR%2BIVDR.png Notícias - Nova versão do Manual de Fronteira e Classificação de Dispositivos Médicos publicada pela União Europeia - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/entender-a-regulamentao-de-dispositivos-mdicos-baseados-em-software monthly 0.5 2025-09-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/dca2d0d6-5f27-4266-b23f-1621c035cd4c/ALT%2BUNDERSTANDING%2BREGULATION%2BSOFTWARE%2BBASED%2BMEDICAL%2BDEVICES.png Notícias - Entender a Regulamentação de Dispositivos Médicos Baseados em Software - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/health-canada-publica-relatrio-sobre-reduo-da-burocracia-regulamentar monthly 0.5 2025-09-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/d3d0460c-19ac-429b-8435-a8f9c05908a4/ALT%2BHEALTH%2BCANADA%2BRED%2BTAPE%2BREDUCTION.png Notícias - Health Canada publica relatório sobre redução da burocracia regulamentar - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-verso-final-da-orientao-ich-e6r3-sobre-boas-prticas-clnicas monthly 0.5 2025-09-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/82015010-1913-4c64-8e35-21cff377edce/ALT%2BFDA%2BGOOD%2BCLINICAL%2BPRACTICE%2BGUIDANCE%2BINDUSTRY.png Notícias - FDA publica versão final da orientação ICH E6(R3) sobre Boas Práticas Clínicas - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mhra-publica-formato-padronizado-para-relatrios-de-vigilncia-ps-comercializao-pmsr monthly 0.5 2025-09-15 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/fc508b1d-c909-403e-abb4-9d7de75c4f6a/ALT%2BMHRA%2BMEDICAL%2BDEVICES%2BPMS%2BREQUIREMENTS%2BREGULATIONS%2BPMSR.png Notícias - MHRA publica formato padronizado para relatórios de vigilância pós-comercialização (PMSR) - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/indstria-da-tecnologia-mdica-apela-simplificao-da-legislao-digital-da-ue monthly 0.5 2025-08-29 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/7d84d12d-a1e0-400b-8b72-c2787ecbb35b/ALT%2BMEDTECH%2BEUROPE%2BMEDICAL%2BTECHNOLOGY%2BINDUSTRY%2BEU%2BDIGITAL%2BLEGISLATION.png Notícias - Indústria da Tecnologia Médica apela à simplificação da legislação digital da UE - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/nova-orientao-mdcg-sobre-master-udi-di-para-lentes-de-contacto monthly 0.5 2025-08-29 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/36dce376-c67a-4e9f-b7a5-cb2a2374e2b7/ALT%2BMDCG%2BMASTER%2BUDI%2BDI%2BIMPLEMENTATION%2BCONTACT%2BLENSES.png Notícias - Nova Orientação MDCG sobre Master UDI-DI para Lentes de Contacto - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-atualiza-orientaes-para-reporte-de-incidentes-adversos-com-dispositivos-mdicos monthly 0.5 2025-08-29 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/8e09b599-bb96-47b8-bd24-9338ea7f199a/ALT%2BAUSTRALIAN%2BREPORTING%2BMEDICAL%2BDEVICES%2BADVERSE%2BEVENTS.png Notícias - TGA atualiza orientações para reporte de incidentes adversos com dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/comisso-europeia-atualiza-requisitos-lingusticos-para-fabricantes-no-mbito-do-mdr monthly 0.5 2025-08-21 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/becd42a3-bec5-4ee8-9acb-318378294245/ALT%2BMDR%2BLANGUAGE%2BREQUIREMENTS%2BMANUFACTURES.png Notícias - Comissão Europeia atualiza requisitos linguísticos para fabricantes no âmbito do MDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/tga-publica-orientaes-atualizadas-para-impresso-3d-de-dispositivos-mdicos monthly 0.5 2025-08-29 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/6c1bc136-fc67-4880-afda-bff5cb90cfea/ALT%2BAUSTRALIAN%2BGOVERNMENT%2BMEDICAL%2BDEVICE%2BMANUFACTURING.png Notícias - TGA publica orientações atualizadas para impressão 3D de dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-publica-orientaes-sobre-o-uso-de-tecnologias-mveis-em-medicamentos monthly 0.5 2025-08-29 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/234f2b9a-69b0-4aef-ae38-e244ee09d1f8/ALT%2BSWISS%2BMEDIC%2BMOBILE%2BTECHNOLOGIES.png Notícias - Swissmedic publica orientações sobre o uso de tecnologias móveis em medicamentos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/swissmedic-publica-documento-de-posio-sobre-desafios-e-prioridades-regulamentares-em-dispositivos-mdicos-e-ivd monthly 0.5 2025-08-21 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/45770569-34bf-4929-baf7-2ceb38d4fd61/ALT%2BSWISS%2BMEDIC%2BSWISSMEDIC%2BPOSITION%2BPAPER.png Notícias - Swissmedic publica documento de posição sobre desafios e prioridades regulamentares em dispositivos médicos e IVD - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/comisso-europeia-publica-estudo-sobre-a-aplicao-da-inteligncia-artificial-na-sade monthly 0.5 2025-08-06 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/e75d3a49-ad2d-46a5-8584-ee6ead5e4f63/ALT%2BSTUDY%2BDEPLOYMENT%2BAI%2BHEALTHCARE.png Notícias - Comissão Europeia publica estudo sobre a aplicação da Inteligência Artificial na saúde - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/medtech-europe-prope-abordagem-mais-proporcional-ao-risco-para-amostragem-tcnica-sob-o-ivdr monthly 0.5 2025-08-04 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/d1e0e0c2-e7f0-48a3-8ff2-2ad39e9c3382/ALT%2BMEDTECH%2BEUROPE%2BIVDR.png Notícias - MedTech Europe propõe abordagem mais proporcional ao risco para amostragem técnica sob o IVDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/om0cj0wy66hs9ugbabxxn21ksgbizj monthly 0.5 2025-08-06 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/59bb87e0-6ee8-46bd-976b-4f2a334fcfca/ALT%2BSTUDY%2BSUPPORTING%2BMONITORING%2BMEDICAL%2BDEVICES.png Notícias - Por que os dados da Comissão Europeia sobre MDR/IVDR são os mais confiáveis para fabricantes? - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/nist-atualiza-diretrizes-de-identidade-digital-com-foco-em-segurana-usabilidade-e-privacidade monthly 0.5 2025-08-05 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/fc76c926-7133-44ab-b585-d16c9b834076/ALT%2BNIST%2BDIGITAL%2BIDENTIFY%2BGUIDELINES.png Notícias - NIST atualiza diretrizes de identidade digital com foco em segurança, usabilidade e privacidade - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/austrlia-lana-consulta-pblica-para-regular-a-inteligncia-artificial-impacto-direto-nos-dispositivos-mdicos-e-ivds monthly 0.5 2025-07-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/049e2837-c9bd-4999-9f82-3a470072c0c4/ALT%2BAUSTRALIAN%2BGOVERNMENT%2BMEDICAL%2BDEVICE%2BSOFTWARE%2BARTIFICIAL%2BINTELLIGENCE.png Notícias - Austrália lança consulta pública para regular a Inteligência Artificial: impacto direto nos dispositivos médicos e IVDs - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-atualiza-orientaes-sobre-qualificao-de-pequenas-empresas-no-mbito-do-mdufa-oportunidade-estratgica-para-fabricantes monthly 0.5 2025-08-01 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c9bf62f9-1d8c-4739-a78f-bc0058504fbc/ALT%2BMEDICAL%2BDEVICES%2BUSER%2BFEE%2BSMALL%2BBUSINESS%2BQUALIFICATION.png Notícias - FDA atualiza orientações sobre qualificação de Pequenas Empresas no âmbito do MDUFA: Oportunidade estratégica para fabricantes - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/notified-bodies-defendem-novo-modelo-de-governao-para-o-setor-dos-dispositivos-mdicos-na-ue monthly 0.5 2025-07-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/6022d3a6-e9c5-4423-9c85-8b0fdb0e12da/ALT%2BNOTIFIED%2BBODY%2BFUTURE%2BGOVERNANCE%2BEU%2BMEDICAL%2BDEVICE%2BSETOR.png Notícias - Notified Bodies defendem novo modelo de governação para o setor dos dispositivos médicos na UE - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/anvisa-publica-o-manual-gquip-2025-reforo-estratgico-para-a-gesto-da-qualidade-de-dispositivos-mdicos monthly 0.5 2025-07-24 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/7a0f990f-a746-48c3-a3e0-83304c43d544/ALT%2BANVISA%2BMEDICAL%2BDEVICES%2BBRAZIL.png Notícias - ANVISA publica o Manual GQUIP 2025: reforço estratégico para a gestão da qualidade de dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/eu4health-2025-comisso-europeia-aprova-programa-de-trabalho-com-foco-na-preparao-para-crises-doenas-no-transmissveis-e-regulamentao-de-dispositivos-mdicos monthly 0.5 2025-07-24 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/da716b6d-c783-4bc8-baac-03e02ac6e058/ALT%2BEU4Health%2BMEDICAL%2BDEVICES.png Notícias - EU4Health 2025: Comissão Europeia aprova programa de trabalho com foco na preparação para crises, doenças não transmissíveis e regulamentação de dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/team-nb-destaca-ausncia-de-enquadramento-para-dispositivos-mdicos-de-diagnstico-in-vitro-rfos-no-ivdr monthly 0.5 2025-07-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/ab25a6f0-565d-4545-a485-0bad4558f839/ALT%2BTEAM%2BNB%2BPOSITION%2BPAPER%2BIVD%2BMEDICAL%2BDEVICES.png Notícias - Team-NB destaca ausência de enquadramento para Dispositivos Médicos de Diagnóstico In Vitro Órfãos no IVDR - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/autoridades-competentes-da-ue-apelam-a-uma-reforma-profunda-do-sistema-regulamentar-dos-dispositivos-mdicos monthly 0.5 2025-07-17 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/97212e1a-b390-47a7-b97c-3f69bdaf0bf3/ALT%2BEUROPEAN%2BMEDICAL%2BDEVICES%2BHMA%2BCAMD.png Notícias - Autoridades Competentes da UE apelam a uma reforma profunda do sistema regulamentar dos dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/anvisa-refora-obrigaes-de-marcao-udi-a-partir-de-julho-de-2025 monthly 0.5 2025-07-14 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/593a365b-ea31-4e70-a9e9-5d1e311eff6c/ALT%2BANVISA%2BUDI%2BPRODUTOS%2BMEDICOS%2BOBRIGATORIEDADE.png Notícias - ANVISA Reforça Obrigações de Marcação UDI a partir de Julho de 2025 - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mdcg-clarifica-prazos-para-a-implementao-do-master-udi-di-em-lentes-de-contacto-armaes-e-culos-de-leitura monthly 0.5 2025-07-10 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/62f21860-0859-48a1-8d49-83993c50e456/ALT%2BMDCG%2BCONTACT%2BLENSES%2BIMPLEMENTATION%2BMASTER%2BUDI%2BDI.png Notícias - MDCG Clarifica Prazos para a Implementação do Master UDI-DI em Lentes de Contacto, Armações e Óculos de Leitura - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/comisso-europeia-refora-estrutura-e-funcionamento-dos-painis-de-peritos-para-dispositivos-mdicos monthly 0.5 2025-07-09 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/8ef2d720-3174-4c0b-b21e-a80819d2194d/ALT%2BCOMISSION%2BIMPLEMENTING%2BDECISION%2BMEDICAL%2BDEVICES.png Notícias - Comissão Europeia reforça estrutura e funcionamento dos painéis de peritos para dispositivos médicos - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-refora-a-cibersegurana-na-produo-de-dispositivos-mdicos-novas-orientaes-para-fabricantes monthly 0.5 2025-07-02 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/43080e3b-4824-4d4a-a668-70a23f05a929/ALT%2BFDA%2BMEDICAL%2BDEVICES%2BSECURING%2BTECHNOLOGY%2BEQUIPMENT.png Notícias - FDA reforça a cibersegurança na produção de dispositivos médicos: novas orientações para fabricantes - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-uma-proposta-de-orientao-sobre-requisitos-de-udi-para-produtos-combinados monthly 0.5 2025-07-02 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/8bed6b9b-4332-4d5f-b6c8-1822404b4675/ALT%2BFDA%2BUDI%2BGUDID%2BCOMBINATION%2BPRODUCTS.png Notícias - FDA publica uma proposta de orientação sobre requisitos de UDI para produtos combinados - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-nova-orientao-sobre-cibersegurana-em-dispositivos-mdicos-o-que-os-fabricantes-devem-saber monthly 0.5 2025-06-27 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/30f71ba6-a633-4e22-8d00-4bd2374cc9c2/ALT%2BFDA%2BCYBERSECURITY%2BMEDICAL%2BDEVICES%2BPREMARKET%2BSUBMISSIONS.png Notícias - FDA publica nova orientação sobre cibersegurança em dispositivos médicos – o que os fabricantes devem saber - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/qualificao-de-software-no-mbito-do-ivdr-nova-orientao-da-team-nb-para-fabricantes monthly 0.5 2025-07-02 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/5304194d-db17-467f-b491-0cdbd1601c0f/ALT%2BTEAM%2BNB%2BSOFTWARE%2BQUALIFICATION%2BIVDR.png Notícias - Qualificação de Software no Âmbito do IVDR: Nova Orientação da Team-NB para Fabricantes - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/instrues-de-utilizao-em-formato-eletrnico-comisso-europeia-alarga-o-mbito-do-regulamento monthly 0.5 2025-07-09 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/080d7600-4bf9-46db-9558-6de238a74050/ALT%2BCOMISSION%2BIMPLEMENTING%2BREGULATION%2BEU%2BMEDICAL%2BDEVICES.png Notícias - Instruções de Utilização em Formato Eletrónico: Comissão Europeia Alarga o Âmbito do Regulamento - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/novo-cdigo-de-conduta-da-team-nb-rumo-a-uma-avaliao-mais-harmonizada-e-transparente monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/fc55fbba-cb4d-4572-9215-545f1dec34cf/ALT%2BTEAM%2BNB%2BNOTIFIED%2BBODIES%2BMDR%2BIVDR.png Notícias - Team-NB's New Code of Conduct: Towards a More Harmonized and Transparent Evaluation - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mhra-lana-ai-airlock-novo-sandbox-regulamentar-para-dispositivos-mdicos-baseados-em-inteligncia-artificial monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/0a9f408f-8b0f-448a-bf47-ec42bf5c2493/ALT%2BAI%2BAIRLOCK%2BAIaMD%2BREGULATORY%2BSANDBOX%2BMEDICAL%2BDEVICES.png Notícias - MHRA launches "AI Airlock": new regulatory sandbox for medical devices based on Artificial Intelligence - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mdcg-2019-11-rev1-nova-orientao-sobre-qualificao-e-classificao-de-software-como-dispositivo-mdico-ou-dispositivo-mdico-de-diagnstico-in-vitro monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/c9f5bfd0-7a67-49d1-984a-e710460f6793/ALT%2BMDCG%2BMEDICAL%2BDEVICES%2BSOFTWARE%2BMDR%2BIVDR%2BGUIDANCE%2BMDSW.png Notícias - MDCG 2019-11 Rev.1 - New guidance on qualification and classification of software as a medical device or in vitro diagnostic medical device - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/reino-unido-publica-novo-modelo-de-relatrio-peridico-de-segurana-psur-para-dispositivos-mdicos-mhra-2024 monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/e92c3673-cf41-46f1-b76e-5d6236d1ba6d/ALT%2BMHRA%2BMEDICAL%2BDEVICES%2BPMS%2BPSUR%2BREGULATIONS.png Notícias - UK publishes new model periodic safety report (PSUR) for medical devices - MHRA 2024 - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/health-canada-publica-novas-orientaes-sobre-a-utilizao-de-normas-tcnicas-para-demonstrar-conformidade-com-o-medical-devices-regulations monthly 0.5 2025-11-18 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/34bef9c3-4994-472d-9718-053613aa6a8b/ALT%2BHEALTH%2BCANADA%2BGUIDANCE%2BSTANDARDS%2BSUPPORT%2BCOMPLIANCE%2BMEDICAL%2BDEVICES%2BREGULATIONS%2BMDR.png Notícias - Health Canada publishes new guidelines on the use of technical standards to demonstrate compliance with the Medical Devices Regulations - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mdcg-publica-guia-sobre-a-aplicao-conjunta-do-mdr-ivdr-e-ai-act-o-que-os-fabricantes-devem-saber monthly 0.5 2025-11-11 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/93bf1270-40cf-47fd-a66d-72b34a3e8641/ALT%2BMDCG%2BAIB%2BMDSW%2BMEDICAL%2BDEVICES%2B2025%2B6%2BMDR%2BIVDR%2BAIA.png Notícias - MDCG publishes guide on the joint application of the MDR, IVDR and AI Act: what manufacturers should know - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mdcg-2025-4-nova-orientao-para-a-disponibilizao-segura-de-apps-mdsw-em-plataformas-online monthly 0.5 2025-11-11 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/eab357ef-92c2-4df9-953f-7d5f429e8bed/ALT%2BMDCG%2BMDSW%2BMEDICAL%2BDEVICES%2B2025%2B4.png Notícias - MDCG 2025-4: new guidance for the secure provision of MDSW apps on online platforms - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/health-canada-inicia-cancelamento-de-licenas-mdel-por-incumprimento-da-reviso-anual monthly 0.5 2025-11-11 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/4e1b4eb1-1920-4381-a67f-e470985d7847/ALT%2BHEALTH%2BCANADA%2BMDEL%2BCOMPLIANCE%2BMEDICAL%2BDEVICES.png Notícias - Health Canada begins canceling MDEL licenses for failure to comply with annual review - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. 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sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/cobertura-de-cdigos-mdrivdr-por-organismos-notificados-relatrio-de-junho-2025-destaca-reas-crticas-com-baixa-designao monthly 0.5 2025-11-11 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/e1e9b842-2e8e-4c53-943c-2488b0972eba/ALT%2BMDR%2BIVDR%2BNOTIFIED%2BBODIES%2BCOVERAGE%2BDESIGNATION%2BCODES.png Notícias - Coverage of MDR/IVDR Codes by Notified Bodies: June 2025 report highlights critical areas with low designation - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/mhra-atualiza-diretrizes-sobre-a-classificao-de-produtos-na-fronteira-com-dispositivos-mdicos-no-reino-unido monthly 0.5 2025-11-11 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/55533373-df2f-46af-a827-74f705306d16/ALT%2BMHRA%2BMEDICAL%2BDEVICES%2BBORDERLINES%2BPRODUCTS.png Notícias - MHRA updates guidelines on the classification of borderline products with medical devices in the UK - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-recomendaes-de-rotulagem-para-redes-cirrgicas-de-hrnia-foco-na-segurana-e-na-seleo-adequada-do-dispositivo monthly 0.5 2025-11-11 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/00613e9f-bec2-4fdd-9d96-dd04427b92d6/ALT%2BFDA%2BPACKAGE%2BLABELING%2BRECOMMENDATIONS%2BGUIDANCE%2BHERNIA%2BMESH.png Notícias - FDA publishes labeling recommendations for hernia mesh: focus on safety and proper device selection - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-nova-especificao-tcnica-m11-para-protocolos-clnicos-harmonizados-eletrnicos-cesharp monthly 0.5 2025-11-11 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diferença. https://www.smartmdr.com/notcias/nova-verso-do-formulrio-mir-v731-publicada-a-4-de-junho-refora-alinhamento-com-codificao-imdrf monthly 0.5 2025-10-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/54637843-fd59-4cd1-a489-3cfacd87978a/ALT%2BMDR%2BIVDR%2BMIR%2BSERIOUS%2BINCIDENTS.png Notícias - New version of the MIR form (v7.3.1) published on June 4 reinforces alignment with IMDRF coding - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/eudamed-verso-2150-novidades-e-correes-na-base-de-dados-europeia-de-dispositivos-mdicos monthly 0.5 2025-10-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/b04b8391-c743-4700-85d9-7fc2dd11997f/ALT%2BEUDAMED%2BRELEASE%2BNOTES.png Notícias - EUDAMED version 2.15.0: New features and corrections to the European database of medical devices - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-publica-projeto-de-orientao-para-submisses-eletrnicas-de-q-submissions-com-novo-modelo-estar monthly 0.5 2025-10-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/022f223d-fa58-40fe-a099-fb945f8cc42f/ALT%2BQSUBMISSIONS%2BFDA%2BMEDICAL%2BDEVICES%2BELETRONIC%2BSUBMISSION.png Notícias - FDA Publishes Draft Guidance for Electronic Q-Submissions with New eSTAR Template - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/fda-refora-programa-de-interaes-com-fabricantes-novo-guia-sobre-o-programa-q-submission monthly 0.5 2025-10-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/e2eef628-9cbc-4bd1-80cd-e7a2aec1783e/ALT%2BQSUBMISSIONS%2BFDA%2BMEDICAL%2BDEVICES%2BSUBMISSION.png Notícias - FDA Strengthens Manufacturer Interactions Program: New Guidance on the Q-Submission Program - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/siud-anvisa-lana-sistema-nacional-de-identificao-nica-de-dispositivos-mdicos monthly 0.5 2025-10-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/bf9afe27-af76-4c4a-8d55-610d113ce518/ALT%2BANVISA%2BSIUD%2BUDI%2BMEDICAL%2BDEVICES%2BIDENTIFICACION%2BSYSTEM.png Notícias - SIUD: Anvisa Launches National System for Unique Identification of Medical Devices - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/medtech-europe-publica-guia-prtico-para-a-utilizao-da-nomenclatura-europeia-de-dispositivos-mdicos-emdn monthly 0.5 2025-10-31 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/f776b69b-83df-4aa4-824c-302e4232bc27/ALT%2BEMDN%2BMEDTECH%2BEUROPE%2BMEDICAL%2BDEVICES.png Notícias - MedTech Europe Publishes Practical Guide for Using the European Medical Device Nomenclature 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medical devices - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/imdrf-atualiza-procedimentos-operacionais-o-que-os-fabricantes-devem-saber monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/5ab07f4b-7d4a-4ca5-ad47-fb9596ecd6af/ALT%2BIMDRF%2BSTANDARD%2BOPERATING%2BPROCEDURES%2BMEDICAL%2BDEVICES.png Notícias - IMDRF Updates Operating Procedures: What Manufacturers Should Know - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/guia-de-utilizador-eudamed-para-dispositivos-legacy-ferramenta-essencial-para-a-conformidade-com-os-regulamentos-europeus monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/075346e0-729c-447f-b39e-3de4848cf140/ALT%2BEUDAMED%2BLEGACY%2BDEVICES%2BREGISTRATION%2BUSER%2BGUIDE.png Notícias - EUDAMED User Guide for Legacy Devices - Essential Tool for Compliance with European Regulations - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/nova-verso-do-guia-de-utilizador-eudamed-para-dispositivos-com-udi-um-recurso-essencial-para-os-fabricantes monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/a265a3b8-b07e-4e05-87ff-ec0fbe666a27/ALT%2BEUDAMED%2BUDI%2BUDIDI%2BMEDICAL%2BDEVICES%2BIVD.png Notícias - New Version of the EUDAMED User Guide for Devices with UDI - An Essential Resource for Manufacturers - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/ateno-fabricantes-de-dispositivos-mdicos-fora-da-ue monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/9fd4e6a4-e34e-42b8-8e94-f8df8c30c4a7/ALT%2BECREP%2BEUREP%2BREPRESENTANTE%2BEUROPEU%2BDISPOSITIVOS%2BMEDICOS.jpeg Notícias - Important Change in the European Authorized Representative Symbol (EC REP → EU REP): Manufacturers Must Update Documentation - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/team-nb-publica-posio-oficial-sobre-a-aplicao-do-ai-act-a-dispositivos-mdicos-com-inteligncia-artificial monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/a88a3b71-4cf2-48b3-9bd8-7cd60e49b02e/ALT%2BTEAM%2BNB%2BMDR%2BMEDICAL%2BDEVICES%2BAIACT%2BARTIFICIAL%2BINTELLIGENCE.png Notícias - Team-NB Publishes Official Position on the Application of the AI Act to Artificial Intelligence Medical Devices - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/team-nb-publica-novo-guia-de-boas-prticas-para-a-submisso-da-documentao-tcnica-no-mbito-do-mdr monthly 0.5 2025-10-30 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monthly 0.5 2025-10-30 https://www.smartmdr.com/notcias/novidade-importante-para-fabricantes-de-testes-covid-19-mudana-na-classificao-dos-testes-rpidos-de-antignio monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/f4c1a5c5-add2-4c5e-8a89-844eaa1bff4a/ALT%2BTEAM%2BNB%2BMDR%2BMEDICAL%2BDEVICES%2BCOVID2%2BIVD.png Notícias - Important news for COVID-19 test manufacturers: change in the classification of rapid antigen tests - Conquiste seu espaço Seja o que for, o modo de contar sua história on-line faz toda a diferença. https://www.smartmdr.com/notcias/oms-publica-diretrizes-sobre-tica-e-governana-da-inteligncia-artificial-na-sade monthly 0.5 2025-10-30 https://images.squarespace-cdn.com/content/v1/670f9763d530cb569dc9c501/071b1c07-35ca-42cd-b388-8f8f1203b8b4/ALT%2BWHO%2BETHICS%2BARTIFICIAL%2BINTELLIGENCE%2BHEALTH%2BGUIDANCE.png Notícias - WHO Publishes Guidelines on Ethics and Governance of Artificial Intelligence in Healthcare - Conquiste seu 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