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Medical Devices Webinar – ISO 13485, MDSAP: Practical Considerations for Changes

March 16, 2017 @ 10:00 - 11:00 UTC+0


Webinar Topic:

ISO 13485, MDSAP: Practical Considerations for Changes

Webinar Date & Time:

Thursday,  March 16, 2017 @

10 - 11 AM EST (NYC, USA)

Webinar Description:

Big changes are coming for medical device manufacturers.  ISO 13485:2016 has been released and Health Canada expects certification to the standard no later than March 1, 2019.  Meanwhile, MDSAP (Medical Device Single Audit Program) moved to the implementation stage in Canada at the beginning of this year.

Manufacturers of Health Canada licensed medical devices must certify through MDSAP by January 1, 2019. This program also applies to companies who are selling in the US, Brazil, Australia, or Japan.  There’s a lot to do!

This webinar will highlight some of the changes and discuss planning to help prepare for audits.

Who should attend?

  • Medical Device manufacturers currently selling or planning to sell in Canada, who may also be selling in the US, Brazil, Australia or Japan
  • Medical Device manufacturers, contract manufacturers, OEMs  currently holding ISO 13485:2003 who will transition to ISO 13485:2016
  • Medical Device contract manufacturers and suppliers to Medical Device manufacturers who are interested in ISO 13485:2016 certification
  • Quality professionals at those firms
  • Regulatory affairs professionals at those firms

Webinar Hosts:

Nancy Ruth - Director, Medical Devices, SRS, Mapi Group


Cathie Rutt - Associate Director, Medical Device Quality, Mapi Group


Register Now:



If you need more information, please email our webinar moderator directly at jcallahan@mapigroup.com


March 16, 2017
10:00 - 11:00
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