February 6-8, 2018Anaheim Convention CenterAnaheim, CA

Use the scheduling tool below to browse all the available sessions, speakers and topics at this year's event. Find the content and sessions to fit all of your educational needs and ensure you get the most out of your time at the show.

Have You Made the Leap? Implementing ISO 13485

Speakers:
Pass Type: Conference (Paid) - Get your pass now!
Conference Track: MD&M: Regulatory & Quality Update
Recording: TBD

The 2016 version of ISO 13485 places greater emphasis on risk management and risk-based decision making, and also contains changes related to the increased regulatory requirements for organizations in the supply chain. This session will highlight updates to the standard you need to be aware of and explain how to adapt your quality management system (QMS) to ensure compliance.

Topics to be covered include:

  • The newest requirements for your QMS, including technical information reports (TIRs)
  • How the latest QMS requirements respond to changes in technology and regulatory requirements
  • Effects of the standard on risk assumption
  • Expectations from Notified Bodies when assessing risk management according