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 arrives, the standard reaction isn't confidence—it's panic.

Most companies try to solve this by hiring expensive consultants who drop a stack of generic templates on a desk and bill by the hour. But having a perfect binder of Standard Operating Procedures (SOPs) doesn't matter if your engineers are too scared to report a bug, or if your leadership team doesn't understand their own quality policy.

I realized the industry didn't need another "Quality Manager for hire." It needed a new way to operate.

That's why I founded QMS.Coach.

Wisdom + Speed = Safety

I built this firm on a simple premise: combine real regulatory experience with modern tools.

• The Wisdom: Years of hands-on medical device quality experience—knowing what auditors look for before they even ask the question.
• The Speed: The "Virtual Backroom." Using AI, I can scan your SOPs, identify regulatory gaps, and draft remediation plans in minutes, not months.

I automated the administrative grunt work so I could focus on the human work.

Three Problems I'm Solving Right Now

I don't do generic consulting. I focus on the three specific areas that actually kill MedTech companies:

1. The "Paper Shield" vs. True Quality Culture — You can pass an audit and still have a dangerous product. I moved away from "checklist compliance" to Quality Culture Training. I teach your leadership team how to build an environment of Psychological Safety, where bad news travels fast so it can be fixed immediately.
2. The Audit "Panic Button" — When the FDA or ISO auditor calls, you don't need a lecture; you need a defense strategy. I built the Remote War Room—real-time, "Front Room" coaching during your inspection, helping your SMEs craft clear, concise, and accurate responses under pressure.
3. The QMSR Transition — The shift from 21 CFR 820 to the harmonized ISO 13485 standard is tripping people up. I use AI to perform instant Gap Analyses, giving you a Red/Yellow/Green readiness scorecard without the weeks of manual review.

My Promise: "Advise Only"

I'm not looking to become a permanent employee on your payroll. QMS.Coach is designed to be a high-impact, low-drag resource.

I give you the tools, the training, and the strategy to manage your own quality system. I don't want to be your crutch; I want to be your coach.

If you are ready to stop fearing the regulator and start building a fortress of quality, let's talk.