Medical Device Project
Mrs. Hester E. Hasper, Ph D is a senior consultant at Medical Device Project since the beginning of 2015. She has experience in the field of medical device regulations as well as pharmaceutical industry.
After becoming a Ph D in Chemistry at the Utrecht University (NL) she worked 5 years in pharmaceutical industry in method development and trouble shooting for QC. Dr Hasper switched to medical device industry to work as a Notified Body auditor and file reviewer at DEKRA for 2,5 years . She served clients ranging from small startup companies in technology hotspots like Israel to large multi-site high risk medical device manufacturers. Being trained as biological safety reviewer for high risk medical devices, Dr. Hasper acted as expert reviewer on biocompatibility. Several projects were successfully completed involving consultation at national health authorities for drug-device combinations. After working at DEKRA, Hester Hasper was employed for 3 years at a pharmaceutical company as team lead of the customer and regulatory support services team.
At Medical Device Project, she fulfills various functions, like QA/RA manager, Project manager/Expert member in desing and development projects for the above mentioned areas of expertise and internal or supplier auditor. Furthermore, being experienced in the field of validation of test methods, cleaning and manufacturing processes, she is able to link risk management with establishing a strategy for analytical method development, sampling and process monitoring.
Friday, May 7, 2021
08:30 – 16:30 CEST