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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.
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?
- 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 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
Examination
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
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
Certification
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. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.
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 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 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 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. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.
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
