Plugins
2 plugins@alirezarezvani
Ra Qm Team
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
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 “iso-13485”
2 skills
mukul975 building-incident-response-playbook
Designs and documents structured incident response playbooks aligned with NIST SP 800-61r3 and SANS PICERL frameworks, covering playbook structure, decision trees, escalation criteria, RACI matrices, and SOAR integration.
24.6k · bundle
mukul975 implementing-ot-incident-response-playbook
Develop and implement OT-specific incident response playbooks aligned with SANS PICERL framework, IEC 62443, and NIST SP 800-82 that address unique ICS challenges including safety-critical systems, limited downtime tolerance, and coordination between IT SOC, OT engineering, and plant operations teams.
24.6k · bundle