Ra Qm Team
by @alirezarezvani · plugin · 10 skills
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.
Install the whole plugin (CLI)
npx skillmds add alirezarezvani/capa-officer
npx skillmds add alirezarezvani/ra-qm-skills
npx skillmds add alirezarezvani/soc2-compliance
npx skillmds add alirezarezvani/qms-audit-expert
npx skillmds add alirezarezvani/gdpr-dsgvo-expert
npx skillmds add alirezarezvani/isms-audit-expert
npx skillmds add alirezarezvani/mdr-745-specialist
npx skillmds add alirezarezvani/iso42001-specialist
npx skillmds add alirezarezvani/quality-manager-qmr
npx skillmds add alirezarezvani/eu-ai-act-specialistSkills in this plugin
- ▌ capa-officer · alirezarezvani bundleManage CAPA investigations, root cause analysis, corrective action planning, and effectiveness verification for medical device quality management systems.
- ▌ ra-qm-skills · alirezarezvaniRoutes 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.
- ▌ soc2-compliance · alirezarezvani bundlePrepare for SOC 2 audits by mapping Trust Service Criteria, building control matrices, collecting audit evidence, performing gap analysis, and assessing Type I vs Type II readiness.
- ▌ qms-audit-expert · alirezarezvani bundleProvides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.
- ▌ gdpr-dsgvo-expert · alirezarezvani bundleScans codebases for GDPR/DSGVO compliance issues, generates DPIA documentation, and tracks data subject rights requests with deadline management.
- ▌ isms-audit-expert · alirezarezvani bundleGuides internal and external ISMS audits for ISO 27001 compliance, including audit planning, control assessment, finding management, and certification support.
- ▌ mdr-745-specialist · alirezarezvani bundleClassify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration.
- ▌ iso42001-specialist · alirezarezvani bundleConduct internal audits against ISO/IEC 42001:2023 by identifying AIMS gaps, building an AI risk register with Annex A control mappings, and generating a 12-month Clause 9.2 audit plan.
- ▌ quality-manager-qmr · alirezarezvani bundleProvides 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.
- ▌ eu-ai-act-specialist · alirezarezvani bundleClassify AI systems under the EU AI Act, determine conformity assessment routes, and track per-role obligations using reference scripts and Article-cited guidance.