Mark Schenk

Mark Schenk


Vice President of Advanced Solutions and Vice President of Regulatory,

Tyber Medical

Mr. Schenk has more than 20 years of experience working in the medical device industry, specifically in quality and regulatory assurance roles. Mr. Schenk was responsible for setting up the entire quality system at Tyber Medical. He oversees regulatory submissions around the world, including MDR compliance and submissions for Tyber Medical.

Mr. Schenk has been responsible for the implementation of more than a dozen ISO 13485 quality systems, as well as numerous FDA and international product regulatory clearances. Previously, Mr. Schenk served as Director of Quality and Regulatory Affairs for Simpact Dental. During his tenure at Simpact, he was responsible for building an ISO 13485 quality system, while receiving regulatory clearances in less than a year from the company’s conception. Prior to Simpact, Mr. Schenk served in senior quality positions at several companies, including Datascope Cardiac Assist Division.

My Session

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June 15,2021

EU MDR: Tackling Today’s Challenges

1:00 pm-2:30 pm

Room 45