Header Artwork
Header Artwork


Chemical characterization of a combination device: from Biological Evaluation Plan to practice

June 30, 2020

10:15 am CET

In this webinar, a biological evaluation plan for a combination device will be gradually built while focusing on the chemical characterization to be performed.
First, we will explain the importance of understanding the exact use of the combination device, definition of the parts of the device that can be of biological or chemical concern for a patient, and the need for a detailed material characterization.
Subsequently, we will elaborate on the chemical characterization for this type of device, taking into account the requirement for Carcinogenic, Mutagenic and Reprotoxic Compounds as specified in section 10.4 in Annex I of the MDR. This is especially important for products falling under article 117.
Finally, we will delve into the necessity of drug-device compatibility in the overall biocompatibility evaluation, and why these important aspects should not be forgotten nor neglected.

For more information and to sign up, please visit: https://www.medteclive.com/en/exhibitors-programme

Annelies Vertommen

Annelies Vertommen

Scientific Improvement Manager

Annelies Vertommen holds a master’s degree in Biology and a Ph.D. in Bioengineering. She started her career at Nelson Labs as a Study Director for extractables and leachables projects for the pharmaceutical industry. In recent years, her focus changed to chemical characterization studies for the medical device industry. She closely follows all changes in this...


Sophie Michel

PhD, Study Director Nelson Labs Europe

Sophie Michel got her PhD in biomedical engineering from the University in Maastricht in 2014. Thanks to her broad experience in chemistry and biocompatibility, she joined the team of Study Directors at Nelson Labs Europe in 2015, where she currently focuses on the biological evaluation of Medical Devices through classical biocompatibility tests and chemical characterization. In 2019, Sophie Michel became a member of the ISO 10993 committee.