EU MDR Technical File Starter Kit: Annex II/III Index, GSPR Checklist Structure, PMS Plan & PSUR Templates

Not eligible for NQT documentation review.

EU MDR Technical File Starter Kit: Annex II/III Index, GSPR Checklist Structure, PMS Plan & PSUR Templates

Technical documentation index with classification and DoC checklists, a GSPR checklist with the 23 Annex I topics paraphrased plus applicability/evidence flags, a PMS data log, and PMS plan and PSUR templates.

What's inside:

- 00_Start_Here_README.pdf

- 01_Technical_Documentation_Starter.docx

- 02_GSPR_Checklist_and_PMS_Data_Log.xlsx

- 03_PMS_Plan_and_PSUR_Templates.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 the European Commission, 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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