About the course

Why should you take this training course?

ISO 13485 Lead Implementer training prepares you to assist an organization in establishing, implementing, managing, and maintaining an ISO 13485-based Medical Devices Quality Management System (MDQMS). You will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems during this training course, and you will be able to improve an organization’s overall performance by consistently providing safe and qualitative medical devices.

Training done in collaboration with


Course Outlines

Course Agenda

Duration: Can be taken at your own pace.

Day 1: Introduction to ISO 13485 and initiation of a MDQMS

  • Course objectives and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Fundamental principles of quality and medical devices
  • Initiating the MDQMS implementation

Day 2 Plan the implementation of the MDQMS

  • Understanding the organization and clarifying the quality objectives
  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project
  • MDQMS scope
  • Quality Policy
  • Definition of the organizational structure

Day 3 Implementation of a MDQMS

  • Definition of the document management process
  • Design of controls and drafting procedures
  • Communication plan
  • Training and awareness plan
  • Product Realization
  • Operations Management

Day 4 MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

  • Monitoring, measurement, analysis and evaluation
  • Internal audit
  • Management review
  • Treatment of problems and non-conformities
  • Improvement
  • Preparing for the certification audit
  • Competence and evaluation of implementers
  • Closing the training

Day 5 Certification Exam (3 Hours)

The “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:

  • Domain 1 Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Domain 2 Medical Devices Quality Management System (MDQMS)
  • Domain 3 Planning a MDQMS implementation based on ISO 13485
  • Domain 4 Implementing a MDQMS based on ISO 13485
  • Domain 5 Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
  • Domain 6 Continual improvement of a MDQMS based on ISO 13485
  • Domain 7 Preparing for a MDQMS certification audit

Course Details

Duration: Up to 6 months

Starts: Upon Registration

Ends: After Examination

You'll be signed up to our PECB platform KATE where you will have access to all training procedures.

  • Certification fees are included on the exam price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued
  • In case of exam failure, you can retake the exam within 12 months for free

Frequently Asked Questions

What are the prerequisites?

A fundamental understanding of ISO 50001 and comprehensive knowledge of implementation principles.

Who should attend?

  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members

How do I maintain my Certification?

PECB certifications last three years. PECB certified professionals must meet the following requirements in order to maintain their certification:

  • CPDs must be submitted to PECB.
  • Annual Maintenance is payable to PECB.
  • Follow the PECB Code of Ethics.

ISO 13485 Lead Implementer – Self-Study


Master the implementation and management of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485

Self-Study Course: €1,000 + VAT