What is a "good" BEP? How to save time and costs by setting up a complete BEP and developing the testing strategy

Biocompatibility should be assessed for all medical devices to ensure patient safety and to fulfil the requirements of regulations (international, local and vertical standards).

A crucial first step is to perform a relevant biological evaluation plan (BEP): all the available information on the medical device should be gathered to evaluate if existing data is enough to understand the biological risks applicable to the medical device during its intended clinical use.

If not, testing should be carried out to fill the gaps in knowledge and to allow to draw a conclusion of the biocompatibility of the medical device evaluated.

The webinar aims to provide an overview of a thorough biological evaluation approach to save time and money when marketing medical devices.