FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
Posts published in “Clinical Trial”
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
Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of…
Patient Engagement in Design and Conduct of Medical Device Clinical Investigations
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials
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…