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Online Training for

Quality Management System Regulation (QMSR)

Learn why the Quality Management System Regulation is important and how it supports your business and compliance drivers.  

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Quality Management System Regulation (QMSR) Online Training

As of February 2, 2026, the FDA will begin to enforce Quality Management System Regulation (QMSR), which is an amended version of the Quality System Regulation (QSR). The QMSR incorporates ISO 13485 and certain parts of ISO 9000. QMSR will improve the quality, safety, and efficacy of medical devices and will also help the United States to better align with other international regulatory agencies. 

PathWise Quality Management System Regulation (QMSR) web based training is an hour-long interactive module which discusses a high-level understanding of why the Quality Management System Regulation (QMSR) is important and how it supports your business and compliance drivers.  The course provides a breakdown of the QMSR requirements and includes subpart detail. It also highlights the differences between FDA and ISO standards.

Training is done through ePath, the PathWise online learning management system. ePath is on-Demand e-learning for targeted knowledge-based learning. Our web based training focuses on terms, definitions, regulations and expectations.

Attendees of the QMSR training course course learn how to:

  • Explain why we follow the FDA QMSR.
  • Identify general compliance expectations.
  • Identify the key elements of the QMSR.
  • Explain the key differences between the FDA, QMSR and ISO Standards.

These are the benefits of the QMSR web based training:

    • Optimizing productivity and training time.
    • Flexible mobile learning using a desktop, laptop, tablet or mobile device.
    • Fulfilling new hire and annual FDA training requirements.

Quality System Regulation is taught as an e-learning course to provide an overview of The Quality System Regulations, ISO 13485, and certain parts of ISO 9000. It can be taken through our ePath learning system on a desktop, phone, or tablet.

QMSR training is appropriate for all employees involved in the manufacture and/or support of the medical device industry.

The QMSR online training module is worth 0.15 CEU credits.

PathWise is accredited by the International Association for Continuing Education and Training (IACET).  PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.

Learners must complete the following in order to earn CEU credit:

  • Verify your electronic signature
  • Complete the full course module on ePath
  • Complete the full instruction module
  • Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment). 

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