Medical Device Design Controls Kit: Design Plan, Traceability Matrix, Design Review, V&V Protocols, Design Transfer

Not eligible for NQT documentation review.

Medical Device Design Controls Kit: Design Plan, Traceability Matrix, Design Review, V&V Protocols, Design Transfer

A traceability matrix (user needs, design inputs, outputs, verification, validation) with broken-link and gap flags, coverage % and a transfer-readiness check. Plus templates for the design plan, input approval, design review, V&V protocol and report, and transfer checklist.

What's inside:

- 00_Start_Here_README.pdf

- 01_Design_Traceability_Matrix.xlsx

- 02_Design_Plan_Review_VV_Transfer_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.

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

Norman Quality Tools is not affiliated with or endorsed by any standards body, certification body, government agency or company named in this description.

More kits at normanqualitytools.com

© 2026 Norman Quality Tools. All rights reserved.