ISO 13485:2016 Transition Training

Intertek’s ISO 13485:2016 Transition Training Course is designed for participants looking for in-depth information about the revised ISO 13485:2016 standard. This 1 day course will cover the differences between ISO 13485:2003 and ISO 13485:2016 standards by focusing on the key changes and educating participants on how to prepare and implement a successful transition.   

Through lectures, discussions and workshops, you'll be able:

  • to achieve an in-depth understanding of ISO 13485:2016 standard and their applications to your own company;
  • to understand the differences between ISO 13485:2003 and ISO 13485:2016 standards
  • regulatory implication with the standard revision
  • regulatory compliance and risk requirements
  • transition requirements for your company

You should attend this course if you are a:

  • Person responsible for planning, implementation and auditing of ISO 13485:2016 quality management system
  • Consultant who wants to gain a better understanding of the ISO 13485:2016 medical devices quality management system
  • Lead auditor/auditor responsible for assessing conformity of medical devices quality management system to ISO 13485:2016 standard
DateLocation
TBD, 2018TBD

Course Fee:

  • US and International Attendees: $995.00 USD per attendee
  • Canadian Attendees: $995.00 CAD per attendee

Deliverables: Each attendee will receive certificate(s) upon successful completion of the course.
Prerequisites: Attendees should have medical devices industry background and experience and some knowledge of ISO 13485:2003 standard prior to joining this course.    
Deliverables: Each attendee will receive an Intertek certificate for 1.6 CEUs (continuing education units) upon successful completion of the course.

To register for this course, please complete the following form. By selecting submit, you agree to the Public Training Terms & Conditions.