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PRE-RECORDED WEBINAR: ISO 13485:2016 – Change? Do I Have To?

By Linda Chatwin

Time To Read Less than a minute

UL expert presenters Linda Chatwin from UL and Walt Murray from MasterControl provide insights and information about the changes to ISO 13485:2016 and how it may impact you and your existing quality management system. During the Question and Answer session, there were also many questions on expectations of the FDA and European Union Notified Bodies.
This 60-minute webinar details the following items in regards to the recent ISO 13485 updates:

  • Considerations included in the update
  • Significant changes
  • Compare the old & new- Risk, Risk, Risk
  • How ISO 9001 fits in – Annexes A and B
  • The impact for compliance

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