Skills and MCP tagged “fda”

ra-qm-skills Alireza Rezvani skill Routes regulatory and quality management queries to 15 specialised skills in the ra-qm-team bundle. Useful when a compliance task does not immediately match a single standard. Claude Code 1,653installs regulatory-affairs-head Alireza Rezvani skill A Claude skill for MedTech regulatory work: prepares FDA 510(k), De Novo and PMA packages, plus CE technical documentation under EU MDR 2017/745. Claude Code 790installs fda-consultant-specialist Alireza Rezvani skill This skill guides FDA pathways for medical devices, QMSR requirements, HIPAA assessments, and device cybersecurity. Use it when planning or reviewing regulatory work. Claude Code 775installs fda-qsr-audit-prep Alireza Rezvani skill This skill checks FDA QSR readiness through 6 forcing questions. Use it before an internal audit, an FDA inspection, or a Form 483 response. Claude Code 17installs