Medical Devices Training

Medical Devices Training

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ISO 13485 Training
ISO 13485 Training
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ISO 13485 Medical device training courses

We understand the challenges of implementing and maintaining quality management systems. We understand because it's what we do, every day of every week; for you, for your customers, and for your bottom line.

We have dynamic course owners around the world, allowing delivery of training in many local languages. Our course owners are subject matter experts and use practical examples from their experiences to bring each lesson to life.



ISO 13485:2016 Medical Devices Training courses

Medical Device Single Audit Program (MDSAP): Fundamentals and Readiness >

Gain the knowledge and skills required to successfully host a MDSAP audit within your organization.Obtain in-depth knowledge about this new type of audit and how your organization is best prepared to support the completion of requirements within the allotted time. Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report.

2 days live online or classroom training course

​CQI and IRCA Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016) (PR369) >

  • Interpret the requirements of ISO 13485 in the context of an audit
  • Describe the purpose of a quality management system and explain the 8 principles of quality management
  • Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011

Classroom based training course

Intro to Pharmaceutical Good Manufacturing Practice Training On-Demand Training >

This one-day course will help in gaining an understanding of the fundamental principles of pharmaceutical GMP and how compliance affects product quality. This course is intended to provide learners with an introduction to the fundamental principles of pharmaceutical GMP (PIC/S), the regulatory environment and product realization through market authorization, manufacturing, and lifecycle requirements.

Online