ISO 13485 Lead Implementer

CTSafe Center is in partnership with PECB to deliver  ISO courses in Vietnam. Professional Evaluation and Certification Board (PECB) is a global provider of training, examination, audit, and certification services for multiple fields.

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:

• Introduction to ISO 13485 and initiation of a MDQMS
• Plan the implementation of a MDQMS
• Implementation of a MDQMS
• MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
• Certification Exam

Examination:

The “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Program (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

Examination Features:

• An open book exam with 12 essay question type in 3 hours. 
• Non-native speakers receive an additional thirty (30) minutes.
• You must make a score of at least 70% to pass this course.
• In case of exam failure, you can retake the exam within 12 months free of charge

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:

 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:

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

 Learning method:

• Self-study. Students are provided with login into our learning platform and the course materials.
• You can contact our tutors or our course advisor based in Vietnam via email or Zalo, WhatsApp for further assistance

Course duration:

Students have 30 days to take a course in self-study method.