Susan Klymowsky, PhD

Susan Klymowsky, PhD

VP International Regulatory Affairs


Susan is qualified and very experienced in project management conducting literature studies, technical writing and editing of medical-scientific-engineering documents, as well as Gap Analyses of all international Quality and Regulatory aspects related to many types of Medical Devices.

Before joining Qserve, Susan was QA/RA Manager for a medical device company manufacturing Class III medical implants.
Expert in due diligence and strategic planning. Susan is an advanced certified biological safety (toxicological) expert for Medical Devices. She has a broad scientific background holding advanced degrees in both Biology, Geology, and Information Science and Technology.

Training activities:
Development and performance of various Training Programmes, in company and in-house. Regulatory Submissions, Sterilization Validation, Biocompatibility, Stability and Shelf-Life, Technical Writing, Design and Development, User Needs/Clinical Evaluation, Usability and Risk Management Training.

Learn more about our services within Regulatory Affairs

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