Results for “regulatory-disclosure”
6 skillsra-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
ai-transparency-reqs
Implements AI transparency requirements under EU AI Act Arts. 13-14 and GDPR Arts. 13-14. Covers user notification of AI interaction, system capability disclosure, limitation documentation, and meaningful information about automated logic. Keywords: AI transparency, EU AI Act, GDPR notification, explainability, automated decision.
228 · 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
privacy-policy
Draft a detailed privacy policy covering data types, jurisdiction, GDPR and compliance considerations, and clauses needing legal review.
22.6k
skills
Provides third-party license attributions for software components included in the product.
0 · bundle
gdpr-compliance
Generate UK/EU GDPR compliance documents — privacy policies, cookie policies, DPIAs, ROPA, DSAR responses, data breach notifications, and consent forms. Use when a business needs GDPR documentation, data protection policies, or privacy compliance.
1 · bundle