Animal tissue & Device Drug Combination Expert
As part of the Regulatory non-active device group, Hen is our expert on devices utilizing biological tissue (animal/human) and devices which incorporate ancillary medicinal substances. Hen has been involved in regulatory compliance projects for several types of non-active devices (from class I to class III high-risk devices) and also in supporting companies with building and maintaining their quality management system.
The key expertise areas of Hen include:
• Design, preparation, and review of technical documentations for a range of medical devices for submission to regulatory authorities
• Clinical Evaluation
• Biological Safety Evaluation
• Risk management
• Building QMS for small companies/start-ups
Hen successfully completed the NAMSA courses “Biocompatibility of Medical Devices” and “Regulatory Toxicology of Medical Devices: An Advanced Course”.
Hen about working at Qserve:
"Working for Qserve gave me a great opportunity to work on a wide range of medical devices and to help our customers bring their devices to the market. I have the chance to work with a team of professional QA/RA people from which I learned and continue to learn on a daily basis."
Before joining Qserve, she worked as a Regulatory Affairs Manager and was responsible for regulatory compliance and registration of cosmetics, medical devices, biocides, combination products and OTC products. She has in-depth knowledge concerning the EU and USA regulatory framework. She has also experience in development of formulations for sustained release drugs and combination products.
Hen has a BSc in Biotechnology engineering and an MSc in Chemistry. Her thesis focused on the characterization of biomaterials using different structural methods (spectroscopy, electron microscopy, crystallography).
Learn more about our services within Regulatory Affairs