Dispositivos Médicos - IPN LAS https://validator.w3.org/feed/docs/rss2.html New EC survey reveals slow progress in MDR and IVDR certifications A quick look at the webinar ‘Mastering the Clinical Evaluation of Medical Devices’, which took place last week Home Medical Devices Update: EU Regulations and Standards for Safe Medical Devices Comissão Europeia divulga novos dados sobre certificações MDR e IVDR MDRU attended the Hospitalar 2024, in Brazil, a renowned Hospitalar trade fair Notified Bodies publish key recommendations for the future governance of EU medical devices Novas propostas para a governação do setor dos dispositivos médicos na UE Comissão Europeia publica formulários atualizados de relatório PMSV para conformidade com o MDR e o IVDR. European Commission Releases Updated PMSV Reporting Forms for MDR and IVDR Compliance MedTech Europe propõe abordagem mais proporcional para amostragem no IVDR 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 Serviços Pós-Mercado EU Releases Q&A Clarifying Strategy on AI Talent and Skills Development INFARMED atualiza orientações sobre interfaces gráficas de utilizador para dispositivos médicos INFARMED Updates Guidelines on Graphical User Interfaces for Medical Devices FDA alarga o uso de inspeções não anunciadas a instalações de fabrico no estrangeiro The US FDA, Health Canada, and UK MHRA released a new document today 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 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 Outros Contacts FDA Expands Use of Unannounced Inspections for Foreign Manufacturing Facilities Proteção de Dados Important Update for IVD Manufacturers: EU MDR/IVDR Deadlines Extended! 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” European Artificial Intelligence Act Gap Analysis Others Global Markets Mercados Globais Contactos Data Protection Marketing Your Medical Device: A Comprehensive Journey Through Regulatory Compliance and Clinical Evaluation Teste e Validação About us Medical Devices Update: Council adopts new measures to help prevent shortages MedTech Europe proposes a more proportionate approach to sampling under the IVDR EU gives final green light to the first worldwide rules on AI Home_en Test and validation