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What Happens If You Miss February 2, 2026
The QMSR deadline is not a suggestion.
February 2, 2026 is when FDA expects compliance. Not "making progress." Not "mostly there." Compliance.
What Non-Compliance Looks Like
If FDA shows up and your QMS doesn't meet QMSR requirements:
483 Observations.y.
Your QMSR Resources Are Here
Your Free Resources
→ QMSR vs 820 Cheatsheet — Side-by-side comparison of what actually changed
→ Top 10 QMSR Gaps Checklist — Priority-ranked gaps with fix recommendations
→ FDA Audit Day Guide — What to do before, during, and after an inspection
Knowing Your Gaps Isn't the Same as Fixing Them
Why Gap Analysis Fails
Three reasons companies stall after identifying gaps:
Wrong priorities. They start with documentation cleanup when risk management is the real issue. QMSR changed the emphasis. If you're fixing the wrong things first, you're wasting time.
The Compliance Cliff: Why We Built the "Virtual Backroom" for MedTech
What happens when you pair practical FDA expertise with next-gen AI? You stop checking boxes and start building culture.
For the last two decades, the Medical Device industry has been stuck in a loop.
Startups are terrified of the FDA. Scale-ups are drowning in paperwork. And when an audit notice
Beyond the CAPA: The Future of QMS Coaching is Predictive
As your QMS Coach, I spend a lot of time helping you build robust, audit-proof CAPA systems. We focus on getting the root cause right, verifying the fix, and proving effectiveness. This is the bedrock of compliance.
But what if we could prevent the failure from ever happening?
For too
The QMS Coach Playbook: 5 Steps to an Audit-Proof CAPA System
As a QMS Coach, I've seen hundreds of quality systems. The single process that tells me the most about a company's health? Its CAPA (Corrective and Preventive Action) system.
A CAPA system isn't just a regulatory "to-do list" (per 21 CFR 820.