A ISO 13485:2016 se encontra em processo de análise crítica sistemática (para maiores informações sobre o processo, favor acessar o guia Guidance on the Systematic…
Posts published in May 2019
May be paywalled – 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.
Corrigenda for MDR and IVDR published in Official Journal
EUDAMED UDI Device Data Dictionary MDR – UDI and device data sets to provide in EUDAMED IVDR – UDI and device data sets to provide…
Priority List of Patient Preference-Sensitive Areas
Reorganization of The Center for Devices and Radiological Health Office of Product Evaluation and Quality Implementing a Team-Based Approach to Medical Device and Radiological Product…
Patient Preference Information (PPI) in Medical Device Decision-Making