ISO 13485 Lead Implementer

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

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

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

For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.

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

• Certification fees are included on the exam price
• Training material containing over 450 pages of information and practical examples will be distributed
• An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
• In case of exam failure, you can retake the exam within 12 months for free

• 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