Plugins

1 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 “iso-14971”

4 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.

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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

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

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