Hen Baron

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).

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