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
Home / Medical / Medical Complete Bundle v2: 15 medical device quality kits (ISO 13485, FDA QMSR, ISO 14971, IEC 62304, MDSAP and more)
Medical Complete Bundle v2: 15 medical device quality kits (ISO 13485, FDA QMSR, ISO 14971, IEC 62304, MDSAP and more)
Not eligible for NQT documentation review (all kits in this bundle). 15 medical device quality kits in one download of editable Word and Excel templates for small device makers and contract manufacturers. $975 if bought separately: save $678.
✓ Instant download✓ Whole-company license✓ Secure Payhip checkout
$297
Buy on Payhip · $297Secure checkout by Payhip. Download link by email right after purchase.
- Instant download, editable files
- One purchase covers your whole company
- Original templates, no copied standards text
- Veteran-Owned & Operated
What's inside
- ISO 13485 Medical Device QMS StarterKit
- FDA QMSR Transition Kit (21 CFR 820)Kit
- ISO 14971 Risk Management KitKit
- Design Controls KitKit
- Process Validation IQ/OQ/PQ KitKit
- Complaint Handling & MDR KitKit
- Cleanroom Monitoring Kit (ISO 14644)Kit
- EU MDR Technical File StarterKit
- Biocompatibility Planning Kit (ISO 10993)Kit
- Sterilization Validation Kit (EO / Steam / Radiation)Kit
- Medical Device Software Kit (IEC 62304)Kit
- Usability Engineering Kit (IEC 62366-1)Kit
- Med Device Supplier Quality KitKit
- MDSAP Audit Prep KitKit
- UDI & Labeling KitKit
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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FDA QMSR Transition Kit (21 CFR 820)
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