Regulatory Affairs

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.