Works with
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
Optimized workflow
This edition turns the source methodology into a repeatable agent workflow with explicit inputs, checkpoints and deliverables.
Quality standard
- Confirm scope and missing inputs before execution
- Ground decisions in available evidence and preserve source constraints
- Return an actionable result with assumptions, risks and next steps
Agent compatibility
The same core method is packaged for Claude, Codex, GPT, Gemini, Cursor and OpenCode.
Permissions & security
Source verified · conversion tested · security signals reviewed