Blog
Audit-informed insights on medical device quality and regulatory compliance.
Practical guidance from a Notified Body Lead Auditor on QMSR, EU MDR, MDSAP, ISO 13485, and the work behind staying compliant.
What FDA Can Now Inspect Under QMSR - and How to Stay Compliant
The FDA QMSR went into effect on February 2, 2026. Most quality teams have updated procedure references and considered themselves QMSR-ready. There is one change almost no one has internalized: the records that used to be off-limits to FDA inspectors are no longer protected.
Read article →