ISO 13485 Lead Implementer

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.

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 types, 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:

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/master-credentials.

To be considered valid, these implementation activities should follow best implementation practices and include the following activities:

1. Drafting a MDQMS plan

2. Initiating a MDQMS implementation

3. Implementing a MDQMS

4. Monitoring and managing a MDQMS implementation

5. Performing continual improvement measures

   
   

General Information

• Certification and examination fees are included in the price of the training course

• Training material containing over 450 pages of information and practical examples will be distributed

• An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.

• In case of exam failure, you can retake the exam within 12 months for free

For additional information, please contact us at info@bonegaconsulting.com.