ISO 13485:2016 Lead Implementer Training

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.

Covered Topics

§  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

Who Should Attend This Course?

§  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

Study Material

§  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

End Of Course Instruction

After completing the session and passing each session examination, the students can take the final exam. Once the final exam is passed, then it is considered as an end of course.