Regulatory intelligence and strategy for medical devices Today, our conversation brings up difficult but necessary questions to think about THE CURRENT STATE OF PREPARATION of…
Posts published by “Marcelo Antunes”
Em preparação para nosso Workshop, iremos postar uma série dedicada à inteligência e estratégia regulatória de dispositivos médicos. Hoje nossa conversa traz perguntas difíceis, mas…
In this brief workshop conducted by the SQR Regulatory Intelligence and Strategy Unit team you will understand the concepts, application of intelligence activities and regulatory…
Venha entender os conceitos, aplicação de atividades de inteligência e estratégia regulatória de dispositivos médicos e os benefícios para o seu negócio! A SQR Consulting…
3-D printing (additive manufacturing) of medical devices
Guidance – Clinical evaluation assessment report template
Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)Search for available translations of the preceding link
Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality…
Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
Actual and potential harm caused by medical software