Tid: 08:00 - 10:00
Sted: Medical Growth House
We address the Clinical Evaluation Report – Collection of clinical data in the conformity assessment for medical devices.
The collection of clinical data is a critical aspect in the conformity assessment process of medical devices, and serves to substantiate a manufacturer’s claim regarding the safety, performance and benefit/risk ratio of a given device. Clinical data is generally understood as evidence on the safety and performance of a medical device based on actual usage of the device, and is typically derived from pre-clinical or clinical investigations, scientific literature and/or clinical experiences with similar devices (source: TUV SUD, links to their website for more in-debth info).
Please join us when we dive into the Clinical Evaluation Report and what it means and entails for you, as a inventor and producer of a medical device. We will have the expert from TUV SUD giving us the expert’s view, but also introduce you to a company that has worked on this for several years.