Plugins

2 plugins

@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 “mdr”

8 skills

Mdr 745 Specialist

Classify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration.

20.4k · bundle

More results

116 Mdr 27c00614

Classifies medical devices under EU MDR 2017/745 Annex VIII rules, including software per MDCG 2019-11, with examples and conformity assessment routes.

Create Tldr Page

Transform verbose documentation into concise, example-driven tldr command references following the tldr-pages project standards.

Update docs/index.md and write Google-style docstrings for NeMo-RL documentation changes.

Creates and manages Architecture Decision Records using the Michael Nygard format, including new ADR creation, retrospective analysis, superseding, deprecating, and index generation.

Converts long-form markdown documents (specs, RFCs, reports, plans) into a single-file HTML page with sticky table of contents, scrollspy, search filter, code-copy buttons, and customizable design tokens.

20.4k · bundle

Grill With Docs

Runs a structured interview that stress-tests a plan against the project's domain model, sharpens terminology, and updates CONTEXT.md and ADRs inline as decisions are made.

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.