meddev-document-review

name	meddev-document-review
description	Expert review, editing, and drafting of medical device registration, FDA submission, EU MDR technical documentation, clinical evaluation, risk management, standards compliance, labeling, IFU, software, cybersecurity, usability, PMS/PMCF, and client regulatory documents. Use when the user provides documents, excerpts, tables, protocols, reports, submissions, deficiency letters, reviewer questions, or draft claims and asks for professional comments, modification suggestions, redlines, gap analysis, writing, rewriting, translation-polishing, audit-style review, or document package preparation.
disable	true

MedDev Document Review

Use this skill to review client materials like a senior medical device registration consultant: precise, constructive, regulation-grounded, and ready for document revision.

Review Workflow

1. Identify document type and purpose.

   • Examples: 510(k) summary, De Novo/PMA module, BDD request, Q-Sub package, technical documentation, GSPR checklist, CER, CEP, PMCF plan/report, PMS plan/report, risk file, V&V report, software documentation, cybersecurity file, usability file, IFU, labeling, clinical protocol, response to questions.

2. Establish review basis.

   • Jurisdiction, pathway/class, intended use, device type, applicable standards/guidance, submission stage, and client objective.
   • If missing, state assumptions and review against likely expectations.
   • For registration-related review, search the configured ima medical-device knowledge bases as a private reference source before or alongside public sources. See references/ima-knowledge-base.md.

3. Review for substance.

   • Completeness, consistency, regulatory logic, evidence sufficiency, standards alignment, risk controls, claims support, traceability, and reviewer readability.