Clinical Evaluation of Medical Devices – Online Course

The Medical Device Regulation (MDR) emphasises the requirement for sufficient clinical evidence for any device to get CE marked. Clinical data are normally needed for being compliant with the general safety and performance requirements (GSPR) of the regulation.

A clinical evaluation is mandatory for all devices and the main output document, the clinical evaluation report, states whether there is enough clinical evidence to support the clinical safety and performance of the device.

Clinical evaluation is an ongoing procedure to collect, appraise and analyse clinical data of pertinence for the medical device. There is a strong relationship between clinical evaluation, risk management and post-market surveillance.

Target group
Quality and regulatory professionals working with medical devices, and other medical device company employees interested in the topic.

Recommended prior knowledge
The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.

Course presentations
Course material will be in English, verbal presentation and discussions in Swedish.

Course leader
Cecilia Emanuelsson, Principal Consultant

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