Regulatory

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.

risk-management-specialist helps AI agents draft ISO 14971:2019 medical device risk work products, including plans, hazard analyses, FMEA tables, risk controls, residual risk summaries, and post-production review inputs. Includes references, templates, and helper scripts for Regulatory Affairs and Quality workflows.

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.

mdr-745-specialist is an EU MDR 2017/745 compliance skill for device classification, Annex II/III technical documentation, clinical evidence, PMS/PMCF/PSUR planning, and notified body readiness. It includes MDR reference guides and a Python gap analyzer for structured compliance review.

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.

gdpr-audit-prep helps teams pressure-test GDPR readiness with six Article-cited DPO questions for RoPA, lawful basis, DPIA, transfers, breach, retention, and evidence gaps before audits or due diligence.

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.

compliance-readiness is a prompt-driven compliance review skill for pressure-testing framework scope, evidence reuse, audit timing, ownership, and readiness gaps before new-framework adoption or certification planning.

compliance-os is a multi-framework compliance orchestration skill for Compliance Review. Use it to assess framework applicability, map control overlap, prioritize reusable evidence, and simulate mock internal audits with JSON templates and Python helper scripts.

ai-act-readiness is a Compliance Review skill for EU AI Act intake, pre-deployment checks, conformity readiness, and annual refreshes. It uses /cs:ai-act-readiness <system> to walk through six article-linked questions on prohibited practices, high-risk status, roles, GPAI triggers, and phase-in dates.

aims-audit is a Claude skill for ISO/IEC 42001 AIMS compliance review, using /cs:aims-audit <scope> and six forcing questions to test scope, policy, risk refresh, and audit evidence before certification, internal audit, or AI-system onboarding.

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.