Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco. Conclusões:Considerando a amostra de indeferimentos de registro sanitário estudada, os…
Posts published in May 2019
NESTcc Solicits Public Comments for Data Quality and Methods Frameworks (Due Friday, June 21, 2019)
Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences
Eudamed Data Exchange Guidelines
Eudamed Data exchange services and entity models introductions
M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations
US FDA – Historical Information about Device Emergency Use Authorizations
Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program
MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019)
New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen