ISO 13485 Lead Implementer

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.