Plugins

3 plugins

ISO 27001 Audit Pipeline

Pressure-test an ISMS and generate audit evidence for ISO 27001 certification readiness.

9 skills · plugin

@alirezarezvani

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 — 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-27001”

5 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.

More results

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

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

Creates a print-friendly architecture or pipeline presentation deck with a blueprint-grid mask, rust-red callouts, and serif typography.