Loading ...

Public Training Course Dates & Information:

Course Catalog PDF Download Catalog »
Private TrainingPrivate Training

A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

Private TrainingGroup Discount Save up to 25%

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 FDA’s Medical Device Quality System Regulation

This course provides a focused introduction to the background and requirements of FDA’s Quality System Regulation (QSR). This course covers the QSR subpart by subpart to identify the requirements. 

For companies interested in learning about ISO 13485:2016 see our related course – Understanding an ISO 13485 Quality Management System – or 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 1.800.472.6477  |  Private 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.


At the end of this workshop, participants will be able to:

  • Understand the purpose, benefits, and objectives of FDA’s Medical Device Quality System Regulation (QSR).
  • Analyze the meaning of the elements of the QSR.
  • Compare the relationship between standards and guidance documents in support of FDA compliance initiatives.
  • Understand international harmonization efforts and their effects.
  • Learn how to read FDA warning letters and recognize situations that warrant warning for QSR deficiencies.
  • Map the requirements of the QSR versus your system and establish audit evidence to support FDA compliance.
  • Know when ISO 13485 compliance is required.


  • The Quality System Regulation (QSR) – an integral aspect of the management system
  • QSR background
  • QSR subpart reviews
  • Recent FDA inspectional observations

Who Should Attend

Designed for those who need to understand and apply the requirements of the QSR, including R&D managers; engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; and other cross-functional team members.

In-Person Days: 2
CEUs: 1.5
Private Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX Private training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

Get answers right now. Call 1.800.472.6477

We use cookies to help us offer you the best online experience. By continuing to use our website or closing this window, you’re providing consent regarding cookies. If you want to learn more read our Privacy Policy.