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Building a Culture of Risk Assessment


Tom Bento (Senior VP of Quality and Regulatory Assurance, Nihon Khoden America)

Location: 210D

Date: Tuesday, February 6

Time: 4:45pm - 5:30pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

Your company shouldn’t be paralyzed by over-analyzing data in determining risk. The amount of time and effort you spend determining risk should be commensurate with the risk and complexity of the device, and this should also hold true during the verification and validation process. In this session, you’ll learn how to right-size your risk assessment efforts and focus on what counts.

Topics to be covered include:

  • How your company can simplify the risk assessment process to make it more defensible during a regulatory or quality audit
  • Best practices for using your company’s culture to apply this process
  • Examining the ties-ins with ISO 13485, ISO 14971, and the new EU Medical Device Regulations
  • Best practices for simplifying your risk-based approach to product development