Ken Block – President, Ken Block Consulting

  • Ken Block is an internationally recognized expert in medtech software regulations. He has been an invited speaker in a half-dozen countries on three continents, covering topics including software validation and regulatory compliance for medical device apps. His regulatory consulting company has offices in Europe, Asia and North America.

    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.