Ken Block – President, Ken Block Consulting

  • Ken Block is an internationally recognized expert in medical device regulations. He has been an invited speaker in many countries on three continents, covering topics such as software validation, quality system compliance and market entry strategy. His regulatory consulting company has offices in Europe, Asia and North America. In addition, Mr. Block has founded medical device startup incubators in Dallas and Tokyo, and has acted as VP QA/RA for several medical device startup companies.​




    Title: Software Validation of Medtech Apps & Wearables

    Synopsis: This session will provide an executable roadmap for properly conducting software validation of medtech apps & wearables. Attendees will be guided through the validation process, starting with intended use and appropriate software requirements, and ending with validation protocols and reports.


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