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xxxxUnderstanding 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: 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

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

 
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. 

In-Person Days: 2
CEUs: 1.5

Virtual Session Details

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.

Online Training Schedule

  • This training is delivered as 4 consecutive half-day sessions.
  • Daily sessions run from 1:30-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

See course dates to find / register for a virtual online session of this course.

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that require a final exam are extended by 2 hours on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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