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EU MDR Medical Device Compliance Specialist

mdr-745-specialist

alirezarezvani/claude-skills

A comprehensive guide for achieving compliance with the EU MDR 2017/745. It covers crucial aspects including medical device classification (Annex VIII), developing technical documentation (Annex II/III), planning clinical evaluation (CER), and establishing post-market surveillance (PMS/PSUR) systems. Ideal for regulatory specialists preparing for Notified Body audits or needing to gap-check technical files.

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