Plugins

2 plugins

@alirezarezvani

14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.

10 skills · plugin

@alirezarezvani

Compliance OS — meta-orchestrator for multi-framework compliance programs spanning 9 frameworks (ISO 27001, ISO 13485, ISO 42001, ISO 14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR). Framework selector, cross-framework control mapper, audit simulator, and consolidated evidence-pool generator (stdlib Python), plus 3 cs-* compliance agents and 3 /cs:* readiness commands.

9 skills · plugin

Results for “fda”

4 skills

Gov Safety Recalls

Search NHTSA vehicle recalls, FDA food/drug recalls, and CFPB consumer complaints via an MCP server for product safety monitoring.

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Gov Disaster Intel

Monitors real-time disaster data from FEMA, NOAA, and USGS, including disaster declarations, weather alerts, and earthquake information.

Provides verified official legal references for business formation, labor, and privacy across the USA, Canada, and all 27 EU member states, with links to government portals and gazettes.

Queries the ClinPGx REST API for pharmacogenomic gene-drug data, clinical annotations, CPIC guidelines, and FDA drug labels, generating markdown reports with CSV tables.