FDA QMSR Transition Kit (21 CFR 820)
Gap assessment mapping the old QSR to the QMSR / ISO 13485, a records matrix and a transition plan. Templates, not regulatory advice.
What's inside →$67Buy now
Home / Medical / ISO 13485 Medical Device QMS Starter
ISO 13485 Medical Device QMS Starter
Quality manual, 10 core procedures, DHF/DMR/DHR templates, ISO 14971-style risk file, CAPA and complaint logs.
✓ Instant download✓ Whole-company license✓ Secure Payhip checkout
$147
Buy now · $147Secure checkout by Payhip. Download link by email right after purchase.
See sample pages (PDF preview)
- Instant download, editable files
- One purchase covers your whole company
- Original templates, no copied standards text
- Veteran-Owned & Operated
What's inside
- Start Here READMEPDF
- Quality Manual ISO13485Word
- Core Procedures QP01-QP10Word
- DHF DMR DHR TemplatesWord
- Risk Management File ISO14971 StructureWord
- CAPA and Complaint FormsWord
- ISO13485 QMS WorkbookExcel
Who it's for
Small medical device makers, startups and contract manufacturers building or tightening an ISO 13485 / FDA quality system.
How delivery works
Pay through Payhip and you get a download link on screen and by email. Files open in Microsoft Office, Google Docs/Sheets and LibreOffice.
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