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”
13 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 iso13485-audit-prep
Pressure-tests medical-device QMS work with six traceability-obsessed questions before internal audits, regulatory reviews, or product launches.
20.4k
drnabeelkhan iso-27001
Applies the ISO 27001 framework to identify, assess, and mitigate security risks in systems, processes, and data handling, providing structured analysis and recommendations.
2
tools-only 042-soc-1d937eaf
Reference for SOC 2, PCI-DSS, HIPAA, and GDPR compliance requirements, including control checklists, evidence collection, and audit preparation guidance.
7 · bundle
github gdpr-compliant
Apply GDPR-compliant engineering practices across your codebase, covering API design, data models, authentication, logging, retention, and cloud infrastructure.
36.2k · bundle
drnabeelkhan sox-sarbanes-oxley-act
Applies the Sarbanes-Oxley Act to assess financial-reporting integrity and IT general controls, mapping executive certification and internal-control areas to auditable evidence for public companies.
2
neuralblitz compliance
Guides implementation of data protection and privacy controls for regulatory frameworks such as GDPR, HIPAA, SOC 2, and PCI-DSS, including audits, retention policies, and data subject requests.
1
drnabeelkhan hipaa
Applies the HIPAA framework to identify, assess, and mitigate security risks in systems, processes, and data handling.
2
drnabeelkhan iso-42001-ai-management-system
Applies ISO/IEC 42001 to establish, audit, or certify an AI Management System, mapping controls to clauses 4-10 and producing governance plans.
2
drnabeelkhan pci-dss
Applies the PCI-DSS framework to identify, assess, and mitigate security risks in systems, processes, and data handling.
2
tools-only 011-main-b36446cb
Enforces GDPR-compliant deployment practices for Google Cloud Run, including Frankfurt region verification, PII-safe logging, data anonymization, retention policies, and CSP configuration.
7 · bundle