MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Posts tagged as “Clinical Investigation”
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
Plano de Ação de Pesquisa Clínica no Brasil
So finally the FDIS of ISO 14155:2020 (edition 3) is out. The ballot ends April 01, so if everything is ok, we will probably have…
Clinical investigations of medical devices – guidance for manufacturers
IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
Patient Engagement in Design and Conduct of Medical Device Clinical Investigations
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials