Susan Klymowsky

VP International Regulatory Affairs

Susan Klymowsky, PhD
VP International Regulatory Affairs

 

Prior to Qserve, Susan was QA/RA Manager for a medical device company manufacturing Class III medical implants.
She 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.

Expertise in due diligence and strategic planning. Susan is an advanced certified biological safety (toxicological) expert for Medical Devices. Susan 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.

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