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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

Understanding an ISO 13485 Quality Management System

This foundational course introduces the background and requirements of ISO 13485:2016 in the medical device supply chain, focusing on the relevance of the standard to organizations considering selling in the European Union, or those being required to gain certification from finished device customers. The class explores ISO 13485 clause by clause, identifies the requirements, and includes hands-on exercises and workshops.

Note: Companies with existing ISO 13485 certifications that need to transition to the most current version will find the Oriel STAT A MATRIX course Transition to ISO 13485:2016 a better fit for their needs. For companies interested in learning about FDA's QSR, see FDA’s Medical Device Quality System Regulation. For a comprehensive understanding of US and international regulations see our course Quality Systems for Medical Devices: FDA’s QSR and ISO 13485:2016

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

 
There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

Objectives

  • Understand the requirements of ISO 13485:2016. 
  • Apply process-based thinking to an ISO 13485-compliant quality management system.
  • Understand what is and is not a medical device, and how medical devices are classified and regulated.
  • Establish the relationship of ISO 13485 to ISO 9001 and the FDA Quality System Regulation 21CFR820.
  • Review the QMS requirements in the ISO 13485:2016 standard.
  • Plan the activities of a registration audit.  

Topics

  • The role of the quality management system
  • The process approach to quality management systems
  • ISO 13485 background
  • ISO 13485:2016 requirements: clause by clause
  • ISO 13485 registration

Who Should Attend

This course is appropriate for anyone who needs to know how to meet the requirements of ISO 13485, including management representatives; RA/QA managers/engineers; internal auditors; compliance and legal; product, project, and program managers; R&D or engineering managers; and other cross-functional team members. 

Number of Days: 2
CEUs: 1.5
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