Clinical Evaluation Plan according to EU MDR 2017/745
There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro…
Clinical Data Management
Medical devices are more and more used within clinical trial operations, especially in the last years with the huge development…
Clinical Evaluation according to EU MDR 2017/745
Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and…
New ISO 14155:2020 Clinical Investigation for Medical Devices
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical devices for human subjects —…