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Hershel Caytak

Consultant - Ottawa ON

Hershel Caytak is a regulatory and medical device consultant that joined the Docusys team in May of 2023. Hershel has over 5 years experience working as a contract medical device evaluator for Health Canada's Medical Device Directorate (General and Restorative, Digital Health Division and Investigative Testing Authorization). His specialty has been evaluation of Class III medical devices including X-ray, CT and Ultrasound systems. Hershel received a BASc in Biomedical Engineering at Jerusalem College of Technology, Israel, a MASc in Biomedical Engineering at Carleton University, Ottawa and a PhD in Electrical and Computer Engineering at the University of Ottawa. He has additional experience as a Biomedical Engineer and a Data Scientist. Hershel is passionate about helping clients navigate complex regulatory and technical challenges that present barriers to device market approval. 


Hershel's Services

  • Provide a regulatory strategy and gap analysis of all requirements required for market approval (Canada and US)

  •  Determine device risk level classification (Canada)

  •  Find predicate device (510 (k) applications)

  • Prepare medical device applications (ITA, Class II and Class III in Canada, 510 (k) in the US)

  • Prepare and coordinate pre submission requests (Canada and US)

  • Support ongoing applications (reply to deficiency letter and additional information requests)

  •  Provide advice for regulatory questions


To discuss your requirements, please do not hesitate to contact us.

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