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.
Examination and Certification
The "Certified ISO 13485 Lead Implementer" exam fully meets the requirements of the Examination and Certification Program (ECP). The exam covers the following competence domains:
- Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Domain 2: Medical Devices Quality Management System
- 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
The "Certified ISO 13485 Lead Implementer" exam is available in different languages including English, French, Spanish and Portuguese.
For more information about the exam, refer to PECB Exam Preparation Guide
After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Provisional Implementer, Certified ISO 13485 Implementer or Certified ISO 13485 Lead Implementer, depending on their level of experience.
A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential.
For more information about the certification process, refer to PECB section on ISO 13485 Lead Implementer