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 separately, $297 here).

- ISO 13485 QMS Starter: quality manual, 10 procedures, DHF/DMR/DHR, risk file, CAPA and complaint logs

- FDA QMSR Transition Kit: 22-row QSR to QMSR / ISO 13485 gap assessment, records matrix, transition plan

- ISO 14971 Risk Management Kit: plan, hazard analysis tied to an editable acceptability matrix, FMEA, benefit-risk, report

- Design Controls Kit: traceability matrix with gap flags, design plan, review, V&V, design transfer

- Process Validation IQ/OQ/PQ Kit: master validation plan, protocols and reports, a sample-size calculator and a Ppk check

- Complaint Handling & MDR Kit: intake and investigation forms, a 21 CFR 803 reportability decision tree, and a log with due dates and trending

- Cleanroom Monitoring Kit (ISO 14644): monitoring log with alert/action flags, gowning qualification, cleaning record, excursion form

- EU MDR Technical File Starter: Annex II/III index, GSPR checklist structure, PMS data log, PMS plan and PSUR templates

- ISO 10993 Biocompatibility Kit

- Sterilization Validation Kit

- IEC 62304 Medical Software Kit

- IEC 62366 Usability Kit

- Medical Device Supplier Quality Kit

- MDSAP Audit Prep Kit

- UDI & Labeling Kit

Standards are referenced by clause number and paraphrased, never copied. Public FDA and EU text is summarized with links.

Built by Matt Norman, US Navy veteran and former SpaceX Falcon 9 quality inspector and QA supervisor (not affiliated with or endorsed by SpaceX). Veteran-Owned & Operated.

Templates, not legal advice and not regulatory advice. Not certification; does not guarantee FDA clearance or approval, CE marking, or any audit or MDSAP outcome. Your regulatory and legal advisers decide what your device needs.

Norman Quality Tools is not affiliated with or endorsed by ISO, IEC, the U.S. FDA, the European Commission or the MDSAP regulatory authorities, 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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