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Medical devices training courses

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Implementation of the Medical Device Regulation (MDR)

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

Learn about the MDR's structure & scope, classification & conformity routes, safety & performance requirements, and developing a post-market surveillance system.


Medical Device Single Audit Program Implementation

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

This two day course enables medical device manufacturers to be audited only once for compliance with the standard and regulatory requirements of multiple authorities.


ISO 13485:2016 Appreciation and Interpretation

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

This course introduces ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS).


ISO 13485:2016 Internal Auditor

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

This two day course helps you improve your Quality Management System and understand best practice to conduct effective internal audits in accordance with ISO 13485:2016.


ISO 13485:2016 Internal Auditor

ISO 13485:2016 Auditor/Lead Auditor – CQI & IRCA Certified

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Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

This IRCA registered four day course details the role & responsibilities of an Auditor/Lead Auditor, processes & planning, gathering evidence and evaluation of findings.


Introduction to the Medical Device Regulation (MDR)

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

This course outlines the structure and revised scope of the MDR, the safety and performance requirements for CE marking and determining the appropriate conformity route.


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