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 / Sterilization Validation Kit (EO / Steam / Radiation)
Sterilization Validation Kit (EO / Steam / Radiation)
Validation tracker for EO, steam and radiation, requalification calendar, BI and dose release log, protocol and report. Templates, not regulatory advice.
✓ Instant download✓ Whole-company license✓ Secure Payhip checkout
$67
Buy on Payhip · $67Secure 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
- Sterilization Validation WorkbookExcel
- Sterilization Validation ProtocolWord
- Sterilization Validation ReportWord
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
Look inside
Included in
Related kits
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
ISO 14971 Risk Management Kit
Risk plan, hazard analysis tied to an editable acceptability matrix, FMEA, benefit-risk and the risk management report. Templates, not regulatory advice.
What's inside →$57Buy now