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The "Advise Only" Approach We are not your fractional Quality Manager. We are your Strategic Advisors.
Your QMS, Simplified. Practical Compliance Backed by AI-Powered Efficiency.
Build a Quality Management System that people actually follow. We help MedTech startups and SMBs survive the FDA QMSR transition and build a culture of quality.
The "Advise Only" Approach
We are not your fractional Quality Manager. We are your Strategic Advisors. QMS.Coach combines hands-on regulatory experience with AI-driven "Virtual Backroom" technology to give you:
- Speed: AI-generated gap analyses and SOP drafts.
- Wisdom: Human coaching on "Quality Culture" and audit defense.
- Safety: A clear roadmap without the overhead of a full-time hire.
Why QMS.Coach?
Most consultants drop a stack of SOPs on your desk and leave. We don't. We focus on the Human Element of quality. A perfect SOP is useless if your team is afraid to use it. We train your leaders to build Psychological Safety, ensuring errors are reported early and audits are boring.
Our Core Focus Areas
- QMSR Readiness: Transitioning from 21 CFR 820 to the new ISO 13485-harmonized standard.
- Audit "War Room" Support: Remote, real-time coaching during FDA or Notified Body inspections.
- Quality Culture: Transforming compliance from a "checklist" into a competitive advantage.