ISO 13485 Lead Implementer

ISO 13485, Quality and Management

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.

Who Should Attend?

This training course is intended for 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; and MDQMS team members.

Learning Objectives

Participants will 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; and 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 are required.

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

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 PECB Implementer Certifications are:

Credential	Exam	Professional experience	MDQMMS project experience	Other requirements
PECB Certified ISO 13485 Provisional Implementer	PECB Certified ISO 13483 Lead Implementer Exam or equivalent	None	None	Signing the PECB Code of Ethics
PECB Certified ISO 13485 Implementer	PECB 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 of the PECB Code of Ethics
PECB Certified ISO 13485 Lead Implementer	PECB 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 of the PECB Code of Ethics
PECB Certified ISO 13485 Senior Lead Implementer	PECB Certified ISO 13483 Lead Implementer Exam or equivalent	Ten Years: Seven years of work experience in Medical Devices Quality Management	Project activities: a total of 1,000 hours	Signing of the PECB Code of Ethics

Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme.

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

Drafting a MDQMS plan
Initiating a MDQMS implementation
Implementing a MDQMS
Monitoring and managing a MDQMS implementation
Performing continual improvement measures

Certification and examination fees are included in the price of the training course
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

Delivery Method
Language	Clear

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