Dispositivos Médicos - IPN LAS https://validator.w3.org/feed/docs/rss2.html A quick look back at our recent webinar “Software as a Medical Device and the Regulatory Implications of AI” Home Comissão Europeia publica formulários atualizados de relatório PMSV para conformidade com o MDR e o IVDR. Notified Bodies publish key recommendations for the future governance of EU medical devices European Commission Releases Updated PMSV Reporting Forms for MDR and IVDR Compliance Novas propostas para a governação do setor dos dispositivos médicos na UE Levantamento da UE destaca limitações no processo de certificação segundo o MDR e o IVDR EU Survey Highlights Certification Bottlenecks Under MDR and IVDR UE publica Perguntas e Respostas que esclarecem a estratégia para o desenvolvimento de talentos e competências em IA EU Releases Q&A Clarifying Strategy on AI Talent and Skills Development 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 Comissão Europeia abre consulta pública para reforçar a Estratégia de IA na Europa INFARMED Updates Guidelines on Graphical User Interfaces for Medical Devices FDA alarga o uso de inspeções não anunciadas a instalações de fabrico no estrangeiro European Commission Opens Consultation to Strengthen the AI Strategy in Europe Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 Sobre FDA Expands Use of Unannounced Inspections for Foreign Manufacturing Facilities Teste e Validação MedTech Europe proposes a more proportionate approach to sampling under the IVDR Outros About us Home_en Test and validation Serviços Pós-Mercado Data Protection Important Update for IVD Manufacturers: EU MDR/IVDR Deadlines Extended! Others Proteção de Dados Global Markets Mercados Globais Contactos 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 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 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 A quick look at the webinar ‘Mastering the Clinical Evaluation of Medical Devices’, which took place last week Contacts Exciting News! The new version of EUDAMED 3.8.0 has been deployed! MedTech Europe propõe abordagem mais proporcional para amostragem no IVDR Gap Analysis