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Results for “eu-regulation”

6 skills
tools-only
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.
7 · bundle
More results
alirezarezvani
Eu AI Act Specialist
Classify AI systems under the EU AI Act, determine conformity assessment routes, and track per-role obligations using reference scripts and Article-cited guidance.
20.4k · 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
alirezarezvani
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
pwdev-solucoes
Design System
Documents, standardizes, and governs a Vue 3 + shadcn-vue design system, including component documentation templates, patterns for forms, empty states, loading states, and feedback, plus a consistency checklist and conventional commit conventions.
2
phuryn
Privacy Policy
Draft a detailed privacy policy covering data types, jurisdiction, GDPR and compliance considerations, and clauses needing legal review.
22.6k
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