Advanced level - Biocompatability tests for medical devices
Medicoindustrien now introduces a new full-day biocompatibility course at an advanced level
Introduction and content
The course includes a detailed overview of the main biocompatibility studies for medical devices with special focus on: the choice of representative product, sample preparation, test procedures according to ISO10993, rationales for failed tests, rationales for omitting tests.
Finally, the requirements for the production of biological evaluations will be reviewed. The course is at a higher level compared to previous years with a greater focus on the types of test available and selection of the appropriate test type and test design. The course will be spiced up and include several workshops and cases with product examples from the medical device industry.
Who should attend?
Anyone responsible for medical device development, regulatory or QA
The course will be conducted in English.
Annette Bitz, Clinical Research and Senior Biosafety Specialist, Ambu
Nick Edwards, Senior Scientist, CiToxLAB Scantox A/S
"The details of biological evaluation is well described and summarized. All the tests were described in a comprehensive manner and gives a full overview on how it works, the necessity of it. It would be easier to order testings in the future as the procedures are more understood now.”
Participant, Fall 2016