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ISO 13485 Lead Implementer

Course Description

ISO 13485 Lead Implementer training is designed to provide all necessary insight into the scoping, implementation and maintenance of a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will learn how a best practice approach can assist in the implementation, as well as how and where to identify reporting metrics, performance indicators, risk indicators and the value of continuous improvement methods.

Course delegates can then choose to sit for the exam. If you pass, you gain the “Certified ISO 13485 Lead Implementer” credential which validates that you have the competence and capabilities to implement ISO 13485 within an organization. 

Target Audience

  • Project team members involved in MDQMS implementation programmes
  • Analysts with implementation responsibilities
  • Individuals responsible for maintaining an MDQMS

Learning outcomes

  • Understand the link between ISO 13485 and other standards 
  • Understand how to conduct context analysis, perform a gap analysis and a business risk assessment in preparation for the implementation of a MDQMS
  • Master the ISO 13485 requirements and learn how to manage change in scope
  • Master the ability to handover to a team responsible for maintaining a MDQMS

Our approach

  • Training is based on Management Systems Best Practice  
  • Modules are illustrated with real world examples
  • Exam questions are based on a case study
  • Practice quizzes are similar to the Certification Exam questions


A foundational understanding of ISO 13485 and awareness of implementation tools.

Course Overview

  • Module 1 Foundational project based considerations 
  • Module 2 The Management System behind an MDQMS 
  • Module 3 Planning an implementation programme 
  • Module 4 Implementing a MDQMS based on best practice 
  • Module 5 Key Performance and Key Risk Indicators 
  • Module 6 Reporting and maintaining a MDQMS 
  • Module 7 MDQMS Certification audit

Course Agenda

  • Day 1: Introduction to ISO 13485 requirements and initiation of a MDQMS project
  • Day 2: Planning of the implementation
  • Day 3: Implementation techniques
  • Day 4: Monitoring, measuring and improving a MDQMS, preparation for a certification audit, and the Certification exam


  • All candidates at official training courses are tested throughout their course with quizzes and exercises, in combination with a final exam held on the last day of the course.  Both elements are a part of the overall score. For this course, the final exam constitutes a 12 question essay type exam which should be completed within 180 minutes. A passing score is achieved at 70%. Self-study candidates can purchase an exam voucher from our Store.
  • Exam results are returned within 24 hours, with successful candidates receiving both a digital badge and a Certificate of Achievement
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