Results for “eu-konformitaetserklaerung”

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.

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration.

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

Guides implementation of the GDPR accountability principle under Articles 5(2) and 24, including documentation requirements for policies, DPIAs, RoPA, training records, and breach logs. Activate when establishing or reviewing accountability measures, preparing evidence portfolios, or demonstrating compliance to supervisory authorities. Keywords: accountability, Article 5(2), Article 24, documentation, compliance evidence, governance.

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