Medical Device QMS Resources
Practical, plain-English guides on the FDA QMSR, ISO 13485, and building a compliant quality system without enterprise overhead — written by Nellie Bushman.
The FDA QMSR Is in Effect: A 10-Point Compliance Checklist
The QMSR replaced the 21 CFR 820 QSR on February 2, 2026 — with no grace period. Walk through ten concrete checks to confirm your QMS is compliant, or find the gaps before an FDA investigator does.
Read the checklist → Regulatory StrategyFDA 21 CFR 820 vs ISO 13485: What's Still Different Under the QMSR?
The QMSR harmonized FDA's quality regulation with ISO 13485:2016 — but the two still aren't interchangeable. Certification vs regulation, audits vs inspections, and the US-specific extras, explained.
Read the comparison → BudgetingHow Much Does a QMS Cost for a Medical Device Startup?
A realistic 2026 breakdown of QMS costs — software, consulting, headcount, and certification — plus the hidden costs of doing it wrong, and how a Virtual QMS changes the math.
Read the cost guide →Have a Question These Guides Don't Answer?
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