Skills and MCP tagged “medical-devices”

risk-management-specialist Alireza Rezvani skill Implements ISO 14971:2019 risk management for medical devices across product lifecycles. It guides hazard analysis, 5x5 matrices, and risk control. Claude Code 862installs quality-manager-qms-iso13485 Alireza Rezvani skill Guides ISO 13485:2016 quality management system work for medical device organizations. Use it to plan QMS implementation, prepare internal audits, and manage document control. Claude Code 784installs 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 qms-audit-expert Alireza Rezvani skill A Claude Code skill that runs an ISO 13485 internal QMS audit from plan to CAPA check: risk-based schedule, evidence, finding classification. Claude Code 747installs