The Practical Playbook for Risk, CAPA, Suppliers, and Drift
The QMSR transition is over. February 2, 2026 was the deadline—and investigations now demand proof your system works, not just proof your documents exist. For a limited time download your free copy and get a practical blueprint for building an investigation-ready system without drowning in red tape.
We’ll email your download link instantly. No spam. Unsubscribe anytime.
Social Proof
“A precise tool for a blunt industry problem.”
QMSR Investigation-Ready cuts through the confusion between a compliant document and a compliant process—bridging Engineering and Quality so risk management is as sharp and reliable as the products we manufacture.
— Randy Herman, VP of Engineering, AccuTec, Inc
“Finally, a guide that moves beyond the binder.”
This book hits the pain points that keep executives up at night—especially the CAPA Death Spiral and treating risk management like static paperwork. It provides the operational fix to make your quality system defensible and live.
— Kathy Jackl, President, Custom Assemblies
If you’re a CEO, VP, decision maker, or owner in medical devices…
You already know this truth: quality is a business risk, not a departmental task.
When quality fails, it hits revenue, margins, growth, reputation—and sometimes patient safety.
Most companies don’t get into trouble because they lack procedures. They get into trouble because the system doesn’t hold under pressure:
- CAPAs pile up and never truly die
- “Minor” supplier changes become major field failures
- Production finds workarounds to hit schedule
- Training gets signed… but behavior doesn’t change
- Documentation and reality quietly drift apart
Then the FDA asks the questions that matter:
- Why was this product released?
- Why did the CAPA close if the issue came back?
- Why does the floor do something different than the SOP?
Why QMSR Investigation-Ready
QMSR Investigation-Ready is a practical playbook for leaders who want:
- Control without bureaucracy
- Compliance that supports growth
- Risk-based decisions you can defend
- A quality system that stays alive after the “update the SOPs” push
This isn’t another textbook. It’s a blueprint for operational execution—what to do before the investigator shows up.
Inside the Playbook: The Five Investigation Triggers (and the Fixes)
- Treating Risk Management as “Just Paperwork”
→ Make risk a live behavior system that drives decisions (not a binder artifact) - The CAPA Death Spiral
→ Triage by risk, stop over-CAPA’ing, and prove effectiveness without paralysis - Lost in Translation: DMR vs. MDF and terminology changes
→ Avoid the interview failure that starts investigations on the wrong foot - Supplier Blind spots
→ Build risk-based supplier control that catches uncommunicated changes - Design Control Drift
→ Stop “continuous improvement” from becoming uncontrolled change and validation gaps
Who This Book Is For
This book is built for:
- CEOs / Owners / Presidents
- VPs of Quality, Regulatory, Operations, Engineering
- Quality Managers, RA/QA leaders, Manufacturing leaders
- Anyone responsible for investigation readiness and system performance
If your current plan is “update SOPs, train, sign forms,” this will show you what’s missing:
Execution + evidence of effectiveness.
What You Get
Get your copy now ( free for a limited time)
Fill out the form and you’ll receive:
- Immediate digital delivery of QMSR Investigation-Ready
- A practical framework to reduce findings risk and prevent system drag
- A playbook to align Engineering + QA and run a defensible system
FAQ
How do I receive the book?
After you submit the form, we’ll email you a download link.
Is this really practical, or just regulation talk?
Practical. The focus is on execution—how systems behave under pressure and what investigators actually look for.
Will this help if we’re already ISO 13485 certified?
Yes. QMSR expands exposure (including internal audits and management review records). This book helps ensure your operational proof is defensible.
What if I don’t want sales emails?
No problem—unsubscribe anytime.