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.
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:
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal.More Information