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Medical devices training courses.

We provide training courses covering MDR, IVDR, MDSAP and ISO 13485:2016.

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Preparing for Transition to ISO 13485:2016

Course Type

  • In-house

Course Type

  • In-house

This one-day course helps those who are responsible for managing the transition of their management system learn about the latest requirements of ISO 13485:2016.


Implementation of the Medical Device Regulation (MDR)

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

This 2-day training covers the MDR, replacing MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Device Directive 90/385/EEC).


Implementation of the In Vitro Diagnostic Device Regulation (IVDR)

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

Our 2-day training covers IVDR structure, classification and conformity, safety and performance reqs, and developing a post-market surveillance system.


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

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.


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 Implementation

Course Type

  • Public
  • In-house

Course Type

  • Public
  • In-house

Learn how to design and implement an effective QMS based on ISO 13485:2016, prepare for certification or improve the effectiveness of your existing management system.


ISO 13485:2016 Implementation

Introduction to the Medical Device Regulation (MDR)

Course Type

  • In-house

Course Type

  • 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.


Introduction to the InVitro Diagnostic MDR EU 2017/746

Course Type

  • In-house

Course Type

  • In-house

This course outlines the structure and scope of the IVDR, its rules, safety and performance requirements for CE marking and determining the conformity route.


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