Jeannette van Loon, PhD

CEO at Medical Device Project B.V (MDProject)

Speaker

Jeannette van Loon is an expert QARA consultant in Medical Device Regulation and specifically in biological safety evaluation including toxicological assessment. She works for almost 25 years for the medical device industry assisting in the design and development processes of medical devices, building Design History Files, writing Technical Dossier for regulatory approval and the set up of Quality Management Systems. In 2008 she founded her QARA consultancy company Medical Device Project B.V. (MDProject).

She is actively involved in the development of European and International standards in the fields of medical devices and biological safety evaluation in particular. Earlier in her career, Jeannette worked as COO at a test and research laboratory specialized in the microbiological and biological safety testing of medical devices. For more than 15 years she was expert technical dossier reviewer for a Notified Body on the topic biological safety evaluation. As Medical Biologist she holds a PhD degree in Biomaterials and wrote her doctoral thesis about “Biocompatibility testing of degradable polymers."