Presenter: Dr Sophie Michel – Associate Biocompatibility Expert
In the evaluation of medical devices for biocompatibility, the assessment of patient safety should be made based on risk rather than on a check-box approach. In this aspect, we will see how to construct a Biological Evaluation Plan as per ISO 10993-1 (2018). The presentation will especially show how understanding patient contact and gathering information is the key in defining an adequate biocompatibility testing program.
*The presentation was recorded at our Open House Event in Leuven on 4 March. At that time there was no indication that the date for the entry into force of the MDR might be postponed.