Leveraging MDSAP to Strengthen MDR Quality Management and Audit Readiness
A regulatory affairs review highlights how MDSAP methodology can help French and EU medical device manufacturers structure quality management, internal audits and conformity control under the EU MDR.
MDSAP Updates Audit Approach Document with Expanded Process-Based Guidance
The updated MDSAP Audit Approach document, MDSAP AU P0002.011, provides detailed instructions for conducting process-based MDSAP audits and integrates the former Audit Model and Process Companion documents.
Team-NB Updates Consensus Position Paper on the MDR Certification Process
Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.
FDA Launches One-Day Inspectional Assessments Pilot
The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.
FDA Draft Guidance Aligns QMS Requirements with ISO 13485: What It Means for Medical Device Manufacturers
The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.
MDCG publishes guide on the joint application of the MDR, IVDR and AI Act: what manufacturers should know
The new MDCG 2025-6 guide, published in June 2025, clarifies the joint application of the AI Act and the European MDR/IVDR regulations for medical devices and IVDs with artificial intelligence systems. The document addresses classification, risk management, life cycle, technical documentation and post-market monitoring. Smart MDR supports manufacturers in integrating these requirements into their quality management system and preparing for audits.