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.

Are you ready for ISO 13485:2016?

Speakers:
  • Grant Palmer (Quality, Regulatory and Pilot Production, Sparton)
  • Jahnavi Lokre (General Management, Business Unit Director, Sparton)
Location: Tech Theater
Pass Types: Expo (Free), Conference (Paid) - Get your pass now!
Free Content & Activities: Tech Theater
Recording: Not Recorded

ISO 13485:2016 - Medical devices — Quality management systems —Requirements for regulatory purposes - was published in March 2016 with a mandatory compliance deadline of March 2019. This latest edition of the standard continues the current trend for marquee standards to emphasize risk evaluation. We have, for many years, seen the term “risk based approach” applied to designed devices. These concepts are now being mandated throughout the organization, not just for designed products. A detail review can provide insight into application of the revised standard to existing QMS to maximize compliance and minimize disruptions to the organization.