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🏥 ISO 13485:2016 medical device quality management system generator

Create a controlled starter implementation pack for a medical-device QMS: run a representative clauses 4–8 gap analysis, then generate editable draft policies, indexes, procedures, checklists and training tools tailored to your device profile. Validate every output against a licensed copy of ISO 13485:2016 and all applicable medical-device regulatory requirements before approval or use. Word + CSV.

QMS scope & device profile

Your shared company profile feeds every generated document. Set it once with the profile button above. The fields below are specific to this medical-device QMS and shape which documents, checklist items and training rows are generated.

Target markets
Existing certifications / regulatory clearances
Tip: your device class, sterility, reuse and target-market choices tailor the generated documents, the equipment checklist and the training matrix. Set them accurately.
Risk-classification rules differ by jurisdiction (e.g. FDA 21 CFR 860 vs EU MDR Annex VIII). The class you pick here is a general risk band used only to tailor this tool, not a regulatory classification decision — confirm the actual class against the rules of each target market.
Scoring guide

ISO 13485:2016 clauses 4–8
Readiness summary
Auto-generated QMS documentation

Each controlled draft is generated from your company profile and device intake. Preview it, download it as Word, or download the combined draft QMS manual; validate every item before approval or use.

ISO 14971:2019 risk-management cross-reference

Clause traceability matrix (master document)

Device-adapted measurement & quality equipment checklist

Role-based QMS training-needs matrix