Recentes

• 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
• Consultation on ICH E6 (R3) Guideline for Good Clinical Practice Annex-2