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ISO 9001 & ISO 13485: Managing & Advancing Your Risk Control Program


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

Location: 210D

Date: Tuesday, February 6

Time: 1:15pm - 3:00pm

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

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

It's time to explore the alignment of these two standards. When comparing versions of the standards, they are not always aligned in intent, content, or structure. Companies must address the differences as they upgrade to the newest version of the standards. This session will provide a summary of what auditors look for compared to previous standards and what you can do to improve your risk control initiatives.

Topics to be covered include:

  • The benefits of having both ISO 9001:2015 and ISO 13485:2016 certification
  • Ways to effectively manage the two standards simultaneously
  • Case examples of how the latest ISO 9001 standard has been implemented