Master the implementation and management of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485
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 “Certified ISO 13485 Lead Implementer” credential. By holding a 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.
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
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
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
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
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
The “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the 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 Implementer Certifications are:
Credential |
Exam |
Professional experience |
MDMS project experience |
Other requirements |
Certified ISO 13485 Provisional Implementer |
Certified ISO 13483 Lead Implementer Exam or equivalent |
None |
None |
Signing the Code of Ethics |
Certified ISO 13485 Implementer |
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 the Code of Ethics |
Certified ISO 13485 Lead Implementer |
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 the Code of Ethics |
Please be informed: Certified individuals who possess the Lead Implementer and Lead Auditor credentials are qualified for a Certified Master credential. More detailed information will be provided soon.
To be considered valid, these implementation activities should follow best implementation practices and include the following activities:
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You will always be updated on news and courses of our company