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Location: Tech Theater, Booth 637
Date: Tuesday, February 6
Time: 11:30am - 12:15pm
Pass Type: Expo (Free), Conference (Paid) - Get your pass now!
Free Content & Activities: Tech Theater
Vault 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.