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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UDI & Labeling Kit
UDI-DI register with GUDID/EUDAMED flags, US and EU label review checklist, label change form and procedure. Templates, not regulatory advice.
✓ Instant download✓ Whole-company license✓ Secure Payhip checkout
$47
Buy on Payhip · $47Secure 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
- UDI Labeling WorkbookExcel
- Label Change ControlWord
- UDI ProcedureWord
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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