What problem does it solve? Medical device registration documents such as FDA submissions, EU MDR technical files, CERs, PMS/PMCF plans, and deficiency responses require expert-level review against regulations and standards, which is slow and error-prone when done manually. ## Core Features & Use Cases - Regulatory Document Review: Reviews 510(k) summaries, De Novo/PMA modules, Q-Sub packages, GSPR checklists, CERs, risk files, software/cybersecurity documentation, labeling, and IFUs against FDA, EU MDR, ISO 13485, and ISO 14971 expectations. - Prioritized Findings and Gap Analysis: Classifies issues as Critical, Major, or Minor with structured tables covering issue, regulatory impact, suggested revision, and evidence needed. - Revision-Ready Drafting: Rewrites weak claims into evidence-linked regulatory language and drafts deficiency response strategies with proposed response text. - Use Case: A consultant receives a draft PSUR and a Notified Body deficiency letter; the skill audits the PSUR against Article 86 and MDCG 2022-21, then drafts point-by-point responses with supporting evidence references. ## Quick Start Ask the assistant to review your attached FDA 510(k) summary or MDR technical documentation section and return prioritized comments with suggested revisions.
