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.
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.
WHO Publishes Transitional List of WHO Listed Authorities for Medical Devices
The World Health Organization has published a transitional list of WHO Listed Authorities for medical devices, supporting regulatory reliance for medical devices and IVDs.