Dispositivos Médicos - IPN LAS https://validator.w3.org/feed/docs/rss2.html European Commission Releases Updated PMSV Reporting Forms for MDR and IVDR Compliance Sandra Balseiro was a speaker on the webinar “Development of the Researcher’s Brochure”, organized by AICIB Home Comissão Europeia publica formulários atualizados de relatório PMSV para conformidade com o MDR e o IVDR. INFARMED atualiza orientações sobre interfaces gráficas de utilizador para dispositivos médicos European Artificial Intelligence Act Orientações de Boas Práticas para a Submissão da Documentação Técnica ao abrigo dos Anexos II e III do Regulamento de Dispositivos Médicos (UE) 2017/745 INFARMED Updates Guidelines on Graphical User Interfaces for Medical Devices FDA alarga o uso de inspeções não anunciadas a instalações de fabrico no estrangeiro FDA Expands Use of Unannounced Inspections for Foreign Manufacturing Facilities Comissão Europeia abre consulta pública para reforçar a Estratégia de IA na Europa European Commission Opens Consultation to Strengthen the AI Strategy in Europe Proteção de Dados Serviços Pós-Mercado Data Protection Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 Sobre Teste e Validação Home_en Test and validation Gap Analysis Important Update for IVD Manufacturers: EU MDR/IVDR Deadlines Extended! EU Releases Q&A Clarifying Strategy on AI Talent and Skills Development About us Regulatory News for Medical Devices: Regulation (EU) 2024/1860 Important Update: MDCG 2020-16 Rev.3 Guidance on IVD Classification RulesImportant Update: MDCG 2020-16 Rev.3 Guidance on IVD Classification Rules Medical Devices Update: New Guidance for Medical Device Standards in the EUMedical Devices Update: New Guidance for Medical Device Standards in the EU Contactos Medical Devices Update: MDCG 2024-10 The FDA released its final guidance document: “Laboratory Developed Tests (LDTs): Small Entity Compliance Guide” Marketing Your Medical Device: A Comprehensive Journey Through Regulatory Compliance and Clinical Evaluation Outros Medical Devices Update: EU Regulations and Standards for Safe Medical Devices The US FDA, Health Canada, and UK MHRA released a new document today MDRU attended the Hospitalar 2024, in Brazil, a renowned Hospitalar trade fair Medical Devices Update: Council adopts new measures to help prevent shortages EU gives final green light to the first worldwide rules on AI Contacts A quick look at the webinar ‘Mastering the Clinical Evaluation of Medical Devices’, which took place last week Exciting News! The new version of EUDAMED 3.8.0 has been deployed! A quick look back at our recent webinar “Software as a Medical Device and the Regulatory Implications of AI” The International Medical Device Regulators Forum (IMDRF) has just released a new final document! Medical Devices Update: New Guidelines for Medical Device Labeling Others News from the European Commission! Delve into the latest advancements in Artificial Intelligence (AI) integration within scientific research across Europe Medical Devices Update – MDCG 2024-4 Global Markets Medical Devices Update Mercados Globais UE publica Perguntas e Respostas que esclarecem a estratégia para o desenvolvimento de talentos e competências em IA