There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro Diagnostic Regulation; this is why having a well documented clinical

Medical devices are more and more used within clinical trial operations, especially in the last years with the huge development of digital medical device technologies; in this context, clinical data

Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance. The evaluation is based on a comprehensive analysis of

Very recently, ISO published a new version of ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. The new ISO 14155:2020 provides an