Quality System Regulation Training For Medical Devices

Training overview
Professional Course
up to 2 hours

Start dates
Virtual instructor led training available

Course description

Quality System Regulation Training For Medical Devices

PathWise Quality System Regulation (QSR) web-based training is an interactive module which discusses a high-level understanding of why the Quality System Regulation (QSR) is important, and how it supports your business and compliance drivers. The course provides a breakdown of the QSR 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.

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Who should attend?

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

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

Training content

Attendees of the QSR Training course will learn how to:

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

Benefits of taking the QSR Training course include: 

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

Why choose PathWise?

Founded in 1998

4000+ classroom learners every year

Over 10,000 users of online courses

About PathWise


In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. PathWise focuses on a solutions-based approach to solving client issues. We help...

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