Medical Device QMS Resources
Six practical, plain-English guides across two tracks — Regulatory Guides and Practical How-Tos — on the FDA QMSR, ISO 13485, design controls, Part 11 e-signatures, and running a compliant quality system without enterprise overhead. Written by Nellie Bushman.
Regulatory Guides
What the rules actually require, and where they're written down.
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 → Design ControlsDesign Controls for Founders Who Have Never Worked in Medtech
Design controls are no longer written out in the CFR — they arrive through ISO 13485 clause 7.3. Here's what that actually means for a first-time founder, and the five records that matter most.
Read the guide →Practical How-Tos
Building, budgeting for, and running the system day to day.
Your First FDA Inspection: A Startup Walkthrough
What actually happens when an investigator walks in — under the inspection program that replaced QSIT on February 2, 2026. Form 482, front room and back room discipline, Form FDA 483 observations, and the NAI, VAI, and OAI classifications.
Read the walkthrough → Part 11 & E-Signatures21 CFR Part 11 Electronic Signatures Without an Enterprise Budget
Part 11 is a set of controls, not a product you buy. Closed-system controls, signature manifestations, the two-component rule, and the certification letter to FDA — and how a small company meets it without enterprise software.
Read the guide → 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 →Follow these guides in your reader: RSS feed
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