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.
2026 MDSAP Forum Outcome Statement Highlights Global Expansion and EU Alignment
The MDSAP Regulatory Authority Council releases the 2026 Forum Outcome Statement, detailing 2025 performance, MDO pilot results, and EU MDR alignment.
MDSAP Extends Pilot Program Allowing Medical Device Organizations to Apply for Certification
MDSAP has extended its voluntary pilot program allowing eligible Medical Device Organizations to participate in and apply for MDSAP certification until April 2027.
Health Canada Updates Guidance for Private Label Medical Device Licence Applications
Health Canada has updated its guidance for Class II, III, and IV private label medical device licence applications. Learn what manufacturers need to know about REP submissions, MDSAP requirements, documentation expectations, and compliance implications.
IMDRF Publishes 2026 Playbook for Medical Device Regulatory Reliance Programs
IMDRF releases its 2026 Playbook for Medical Device Regulatory Reliance Programs, outlining work-sharing, recognition and abridged pathways.