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- Como implementar, manter e rever o Sistema CAPA: “Ótima formação com partilha de exemplos reais e práticos”
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
- Total Product Lifecycle Considerations for Generative AIEnabled Devices
- MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)
- Team-NB High level position on the regulatory framework for the medical devices sector
- CONTROLO DE ALTERAÇÕES : Sessão esclarecedora com uma discussão bastante interessante sobre o assunto
- EU Prosperity and Competitiveness: Recommendations for implementing the EU Green Deal in Healthcare