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”
7 skills
k-dense-ai iso-13485-certification
Prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, template-based document creation, and compliance checklists.
30.2k · bundle
alirezarezvani ra-qm-skills
Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.
20.4k
More results
alirezarezvani qms-audit-expert
Provides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.
20.4k · bundle
alirezarezvani quality-manager-qmr
Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2 for HealthTech and MedTech companies.
20.4k · bundle
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
huuanh20 sr-improve
Generates a candid improvement report for a software requirements specification, covering deferred features, technical risks, FR refinements, NFR gaps, validation warnings, and process recommendations.
1 · bundle