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

ISO 13485 Lead Implementer

Why should you attend?

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.

After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “Certified ISO 13485 Lead Implementer” credential. By holding a Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization. 

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

Learning objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks 

  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS

  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization

  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS

  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

Educational approach

  • This training is based on both theory and best practices used in the implementation of a MDQMS

  • Lecture sessions are illustrated with examples based on case studies

  • Practical exercises are based on a case study which includes role playing and discussions

  • Practice tests are similar to the Certification Exam

Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

Course agenda

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

Day 2: Plan the implementation of a MDQMS

Day 3: Implementation of a MDQMS

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

Day 5: Certification Exam

Examination

The “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the 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

Certification

After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. 

The requirements for Implementer Certifications are:

Credential

Exam

Professional experience

MDMS project experience

Other requirements

Certified ISO 13485 Provisional Implementer

Certified ISO 13483 Lead Implementer Exam or equivalent

None

None

Signing the Code of Ethics

Certified ISO 13485 Implementer

Certified ISO 13483 Lead Implementer Exam or equivalent

Two Years: One year of work experience in Medical Devices Quality Management

Project activities: a total of 200 hours

Signing the Code of Ethics

Certified ISO 13485 Lead Implementer

Certified ISO 13483 Lead Implementer Exam or equivalent

Five Years: Two years of work experience in Medical Devices Quality Management

Project activities: a total of 300 hours

Signing the Code of Ethics

Please be informed: Certified individuals who possess the Lead Implementer and Lead Auditor credentials are qualified for a Certified Master credential. More detailed information will be provided soon.

To be considered valid, these implementation activities should follow best implementation practices and include the following activities:

  1. Drafting a MDQMS plan
  2. Initiating a MDQMS implementation
  3. Implementing a MDQMS
  4. Monitoring and managing a MDQMS implementation
  5. Performing continual improvement measures

General Information

  • 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