Fda

clinical-research helps teams design prospective clinical studies before submission, with endpoint classification, two-arm sample size and power estimates, and feasibility phase-gate scoring. It includes Python tools, references, and a protocol synopsis template, while keeping outputs as estimates for clinician, biostatistician, and regulatory review.

regulatory-affairs-head is a Claude skill for medical device and HealthTech regulatory planning, including FDA 510(k), De Novo, PMA, EU MDR technical documentation, CE marking, global pathways, ISO mapping, deficiency responses, and submission tracking with included references and scripts.

qms-audit-expert is an ISO 13485 internal audit skill for medical device QMS teams. It supports risk-based audit planning, clause checklists, nonconformity classification, CAPA verification, external audit prep, and schedule optimization using included references and a Python tool.

iso13485-audit-prep is a GitHub skill for ISO 13485 QMS compliance review. It pressure-tests DHF, CAPA, complaints, supplier controls, management review, and post-market evidence before audits, MDR/FDA QSR checks, launches, or CAPA follow-up.

fda-qsr-audit-prep is a Compliance Review skill for FDA medical-device QSR audit readiness. Use it to pressure-test complaint files, MDR decisions, CAPA links, process validation, Form 483 responses, and QMSR transition evidence with six inspection-style questions.

general-counsel-advisor is a Claude skill for startup legal triage: contract risk review, IP ownership checks, term sheet decoding, and regulatory exposure mapping. Includes references and Python scanners to prepare counsel-ready issue lists, not legal advice.

iso-13485-certification helps medical device teams prepare ISO 13485:2016 certification documentation. Use it for gap analysis, Quality Manual drafting, required procedures, work instructions, Medical Device File content, and audit prep. It is especially useful for technical writing and certification-ready QMS documentation.

clinical-reports is a structured writing skill for clinical case reports, diagnostic reports, clinical trial reports, and patient documentation. It supports CARE, ICH-E3, HIPAA, FDA, and ICH-GCP workflows, with clear templates and guidance for accurate, de-identified, publication-ready clinical writing.