ISO 13485 Medical Device QMS Starter
Quality manual, 10 core procedures, DHF/DMR/DHR templates, ISO 14971-style risk file, CAPA and complaint logs.
What's inside →$147Buy now
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Design Controls Kit
Traceability matrix with gap flags, design plan, design review, V&V protocol/report and design transfer templates. Templates, not regulatory advice.
✓ Instant download✓ Whole-company license✓ Secure Payhip checkout
$77
Buy on Payhip · $77Secure 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
- Design Traceability MatrixExcel
- Design Plan Review VV Transfer TemplatesWord
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.
Questions? Support
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Included in
- Complete Quality Toolkit v3: all 25 kits · $397
- Medical Complete Bundle v2: 15 medical device quality kits (ISO 13485, FDA QMSR, ISO 14971, IEC 62304, MDSAP and more) · $297
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