ISO 13485 Lead Implementer

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Course Overview

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 “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB 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.

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


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

Target Audiance

  • 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

Schedule Dates

ISO 13485 Lead Implementer
25 March 2024 - 29 March 2024
ISO 13485 Lead Implementer
01 July 2024 - 05 July 2024
ISO 13485 Lead Implementer
07 October 2024 - 11 October 2024
ISO 13485 Lead Implementer
13 January 2025 - 17 January 2025

Course Content

  • Introduction to ISO 13485 and initiation of a MDQMS

  • Plan the implementation of a MDQMS

  • Implementation of a MDQMS

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

  • Certification Exam


ISO 13485 Lead Implementer refers to an advanced level of training and certification focused on equipping professionals with the knowledge, skills, and tools necessary to lead the implementation of a Quality Management System (QMS) based on the ISO 13485 standard for Medical Devices. This certification enables individuals to effectively plan, execute, monitor, and improve a QMS to meet the specific requirements of ISO 13485 within organizations involved in the medical device industry.

ISO 13485 Lead Implementer certification is ideal for professionals involved in quality management, regulatory affairs, and compliance within organizations manufacturing, distributing, or servicing medical devices. This includes quality managers, regulatory affairs professionals, compliance officers, and individuals responsible for implementing and maintaining QMS in accordance with ISO 13485 requirements. It is also beneficial for consultants and auditors seeking to specialize in medical device quality management.

ISO 13485 Lead Implementer training covers a comprehensive range of topics, including the principles and requirements of ISO 13485, QMS documentation and implementation, risk management for medical devices, process approach to quality management, regulatory requirements, product realization, validation, verification, and improvement of QMS processes. Participants also learn about the importance of customer focus, leadership, and the role of top management in ensuring the effectiveness of the QMS.

Obtaining ISO 13485 Lead Implementer certification offers several benefits, including:

  • Enhanced capability to lead and drive the successful implementation of a Quality Management System aligned with ISO 13485 requirements for medical devices.
  • Increased confidence in ensuring compliance with regulatory requirements and achieving ISO 13485 certification, leading to improved market access and customer trust.
  • Improved ability to identify and address specific risks and opportunities related to the design, development, production, and distribution of medical devices.
  • Recognition as a qualified professional with specialized expertise in medical device quality management, enhancing credibility and career advancement opportunities within the industry.
  • Contribution to the enhancement of product quality, safety, and regulatory compliance, ultimately leading to improved patient outcomes and stakeholder satisfaction.
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