Medical Device Software Kit (IEC 62304)

Not eligible for NQT documentation review.

Medical Device Software Kit (IEC 62304)

A lifecycle checklist by clause number, a requirements-to-test traceability matrix that flags untested and failed items, a SOUP register that flags missing reviews, a problem report log, an SDP template and a safety class and release checklist.

What's inside:

- 00_Start_Here_README.pdf

- 01_IEC62304_Medical_Software_Workbook.xlsx

- 02_Software_Development_Plan.docx

- 03_Safety_Class_and_Release.docx

Written by Matt Norman: 15 years as a U.S. Navy aviation structural mechanic, then 3 years at SpaceX as a Falcon 9 quality inspector and QA supervisor, with hands-on experience working under ITAR and DoD compliance requirements. Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

Templates, not regulatory advice.

Norman Quality Tools is not affiliated with or endorsed by IEC, or any other standards body, government agency or company named in this description. Standards are cited by number only; buy the official standard from its publisher.

Not affiliated with or endorsed by SpaceX or any other current or former employer of the author.

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