Software Development

MDR 745 Specialist

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').

Publisher / source

Claude Skills Collection

Upstream record

alirezarezvani/claude-skills

Version

Version 3

Published

2026-05-06

Publication review

Approved for publication

Content fingerprint

3c4d15205caaa9a809b1a03c4c8c05533430236f597ecd68bd7bde12b16a4964