QMSR Readiness
A clause-by-clause review of where your quality system stands against QMSR, prioritized by what an inspector is actually likely to ask for first, not by clause order.
QMSR readiness
FDA's QMSR Took Effect February 2026.
Enforcement is already underway. The FDA's Quality Management System Regulation replaced the old Quality System Regulation this year, and inspectors are already citing companies under the new framework. Here's what's changed, and how I can help you get ready or respond.
What Changed
FDA's QMSR amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. It took effect February 2, 2026, with no grace period. Inspections happening right now use the new framework.
According to industry analysis of FDA's inspection database, 89.7% of Form 483 observations issued since QMSR took effect cite ISO 13485 clauses directly, not the legacy Part 820 language most quality teams trained on. (Source: RegulatoryIQ analysis of FDA's Inspectional Observation Database, cumulative through June 2026.)
Risk management, ISO 13485 Clause 7.1, is the single most cited area in early QMSR enforcement data. Teams are being cited for documenting risk controls they can't demonstrate were actually implemented or verified.
Records that were off-limits to FDA inspectors for decades, internal audit reports, supplier audit reports, and management review minutes, are now inspectable. The exemption that protected them under the old QSR doesn't exist under QMSR.
Why Work With Me
QMSR is, at its core, ISO 13485. I've been building and defending ISO 13485-aligned design and quality systems for 25 years, at companies like Stryker and NuVasive, on knee systems, instrumentation, and spine robotics. The top citation area in early QMSR enforcement is risk management, and I've done ISO 14971 risk management hands-on, as an engineering leader responsible for the outcome, not as an outside reviewer checking paperwork after the fact.
Where I Can Help
483 Response Support
If you're already holding a Form 483 or warning letter, support building the response, the CAPA, and the effectiveness verification plan behind it.
Risk Management File Remediation
Direct work on your ISO 14971 risk management file, the single most-cited area in QMSR inspections so far.