ISO 13485 Lead Implementer Training

Why should you attend?

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.

The successful completion of the training course is followed by an exam. If you successfully pass the exam, you can have for the “Megademi ISO 13485 Lead Implementer Certificate recognized by Exemplar Global”. This certificate validates your professional capabilities and demonstrates that you have the knowledge and skills to audit a MDQMS based on ISO 13485.

Who should attend?

  • 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

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

Prerequisites

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

Course Agenda

Day 1: Introduction to ISO 13485 and the initiation of a MDQMS implementation

Day 2: Implementation plan of a MDQMS

Day 3: MDQMS monitoring, continual improvement, and preparation for the certification audit, Certification exam

Examination and Certification

After completing 3 days lead implementer course, participant take exam including all subjects of above training. After successfully completing the exam, you will have Megademi Lead Implementer Certificate recognized by Exemplar Global. 

Exemplar Global and CPD Certified Course                      Exemplar Global Lead Auditor - Competitive Edge Performance Solutions       

For additional information, please contact training@megademi.com

Megademi is approved training partner by Exemplar Global for ISO Courses.

Exemplar Global has been accredited for Management System Auditor courses and personnel accreditation. Formerly known as RABQSA, Exemplar Global has over 30 years of expertise building certification programs for the conformity community. RABQSA was established in 2004 from the merger of the personnel certification activities of the U.S Registrar Accreditation Board (RAB) with the Australia-based Quality Society of Australasia (QSA).