Decide what applies before you write a single procedure.
Every requirement that applies stays. Your auditor still decides. What changes is that each call has a written reason and a clause next to it.
FDA's QMSR now runs on ISO 13485.
Since February 2, 2026, FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference. FDA inspectors can now review management reviews, internal audits and supplier audit reports.
For a one-person quality team, that means one system for the U.S. and EU, and less room for "we'll document it later."
The path
- Free applicability sample: check how we cite before you pay
- QMS Roadmap Session ($450): your applicability list, a reason on every line
- ISO 13485 Kit ($697) or Kit + Review ($1,297)
- Gap assessment ($3,500–$6,500), after a session
- Case Keeper retainer, month to month
Clause by clause, in plain English.
Clause 4 · QMS
Scope, outsourced processes, QMS software validation, the Medical Device File.
Clause 5 · Management
Policy, objectives, management representative, management review inputs.
Clause 6 · Resources
Competence, infrastructure, work environment and contamination control.
Clause 7 · Realization
Risk management, design controls, purchasing, production, traceability.
Clause 8 · Improvement
Feedback, complaints, regulatory reporting, internal audit, CAPA.
Market notes
U.S. QMSR, EU MDR, and South Korea KGMP deltas, marked where they add to ISO 13485.
What does it cost not to have one person checking the calls?
A full-time quality manager typically costs $142,000+ a year. A retainer isn't a replacement for a hire. It's a fixed monthly amount for a defined number of hours on the questions that can't wait for one.
Start with what applies to you.
Download the free applicability sample, or book a QMS Roadmap Session.