Skill UI

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.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

This router bundles 15 specialized compliance skills crucial for HealthTech and MedTech organizations. It provides structured guidance across major global regulations, including ISO 13485 QMS, EU MDR, FDA submissions, GDPR, and the EU AI Act. Use this when a compliance request is complex and needs to be accurately directed to a specific technical skill area (e.g., risk management, CAPA, data security).

A comprehensive toolkit for medical device manufacturers seeking ISO 13485 certification. This skill guides users through gap analysis, creating mandatory Quality Management System (QMS) documentation, and ensuring compliance with global medical device regulations (e.g., EU MDR, FDA QMSR). It provides templates, guidance, and structured processes for foundational QMS documents like Quality Manuals and CAPA procedures.

Organizes declared scope, controlled documents, risk files, traceability, and readiness evidence for ISO 13485, ISO 14971, ISO/IEC 17025, and ISO 15189 human review, with deterministic local checks and separate certification, accreditation, FDA QMSR, and EU MDR/IVDR evidence boundaries.

This skill guides the assessment and drafting of Serious Incident Reports (SIR) required under Article 73 of the EU AI Act. It helps legal, compliance, and product teams determine if an AI failure or adverse event qualifies as a reportable serious incident. The process covers scoping, deadline assessment (2/10/15 days), identifying relevant market surveillance authorities, and cross-mapping obligations with regulations like GDPR, NIS2, and MDR. Use it to create comprehensive incident playbooks and actionable compliance memos.