What is included?

• You have 12 months time as of reception of the learning material to learn, do the exam and get your certification
  
• 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 candidates do not pass the exam, they are entitled to a free retake within 12 months from the date the coupon code is received  
• + 20% reduction on the first year subscription for our all-in-one ISMS/GRC management solution
  

Why should you take this training course?

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?

The ISO 13485 Lead Implementer training course is intended for:

• 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

Training course structure

Module 1: Introduction to ISO 13485 and initiation of a MDQMS

• Course objectives and structure
• Standard and regulatory framework
• Medical Devices Quality Management System (MDQMS)
• Fundamental principles of quality and medical devices
• Initiating the MDQMS implementation

Module 2: Plan the implementation of the MDQMS

• Understanding the organization and clarifying the quality objectives
• Analysis of the existing management system
• Leadership and approval of the MDQMS project
• MDQMS scope
• Quality Policy
• Definition of the organizational structure

Module 3: Implementation of a MDQMS

• Definition of the document management process
• Design of controls and drafting procedures
• Communication plan
• Training and awareness plan
• Product Realization
• Operations Management

Module 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

• Monitoring, measurement, analysis and evaluation
• Internal audit
• Management review
• Treatment of problems and non-conformities
• Improvement
• Preparing for the certification audit
• Competence and evaluation of implementers
• Closing the training

Certification Exam

Learning objectives

Upon successfully completing the training course, you will be able to:

• 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

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

Duration: 3 hours
Location: Online through the PECB app OR in person in one of the PECB exam centers
Preparation: PECB Exam Preparation Guides
Language: The exam is available in multiple other languages and does not need to be taken in the same language as the training material. Additional time can be requested when your native language is not available in your mother tongue (to be requested by candidates on the exam day)
Retake: In case you fail the exam, you can retake it within 12 months following the initial attempt for free

For specific information about the 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 the 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 visit 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:

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

Contact us on [email protected] if you have other questions