ISO 13485 Lead Implementer
Why should you attend?
The ISO 13485 Lead Implementer training equips you with the essential skills to support an organization in establishing, implementing, managing, and maintaining a Medical Devices Quality Management System (MDQMS) based on the ISO 13485 standard. This course provides a comprehensive understanding of best practices for Medical Devices Quality Management, enabling you to enhance an organization’s performance by consistently delivering safe and high-quality medical devices.
After mastering the core concepts of Medical Devices Quality Management Systems, you’ll be prepared to take the certification exam and earn the “PECB Certified ISO 13485 Lead Implementer” credential. With this certification, you’ll demonstrate your ability to implement ISO 13485 in an organization, showcasing your practical knowledge and professional capabilities in medical device quality management.
Who should attend?
- Managers or consultants in Medical Devices Quality Management
- Expert advisors aiming to master MDQMS implementation
- Individuals responsible for MDQMS compliance
- MDQMS team members
Learning objectives
- Understand the correlation between ISO 13485 and other regulatory frameworks
- Master the methods and techniques for effective MDQMS implementation and management
- Learn to interpret ISO 13485 requirements within an organizational context
- Support an organization in planning, implementing, managing, monitoring, and maintaining an MDQMS
- Acquire expertise to advise on best practices for Medical Devices Quality Management
Educational approach
- Theory-based training supported by MDQMS best practices
- Lecture sessions enhanced with case studies and examples
- Practical exercises include role-playing based on a case study
- Practice tests that mirror the Certification Exam
Prerequisites
- A foundational understanding of ISO 13485 and knowledge of implementation principles
Course Agenda
- Day 1: Introduction to ISO 13485 and initiation of a MDQMS
- Day 2: Planning the implementation of a MDQMS
- Day 3: Implementing a MDQMS
- Day 4: MDQMS monitoring, measurement, continuous improvement, and certification audit preparation
- Day 5: Certification Exam
Examination
The “PECB Certified ISO 13485 Lead Implementer” exam aligns with the PECB Examination and Certification Programme. It assesses skills across seven competency domains:
- Fundamental principles and concepts of a MDQMS
- MDQMS framework and structure
- Planning MDQMS implementation based on ISO 13485
- Implementing MDQMS based on ISO 13485
- MDQMS performance evaluation and monitoring
- MDQMS continual improvement
- Preparing for MDQMS certification audit
For detailed information on exam formats, available languages, and additional specifics, please contact us .
Certification Requirements
To qualify for PECB Implementer Certifications, candidates must meet the following criteria:
| Credential | Exam | Professional Experience | MDQMS Project Experience | Other Requirements |
|---|---|---|---|---|
| PECB Certified ISO 13485 Provisional Implementer | Pass the PECB ISO 13485 Lead Implementer Exam or equivalent | None | None | Sign the PECB Code of Ethics |
| PECB Certified ISO 13485 Implementer | Pass the PECB ISO 13485 Lead Implementer Exam or equivalent | 2 years (1 year in Medical Devices Quality Management) | 200 hours | Sign the PECB Code of Ethics |
| PECB Certified ISO 13485 Lead Implementer | Pass the PECB ISO 13485Lead Implementer Exam or equivalent | 5 years (2 years in Medical Devices Quality Management) | 300 hours | Sign the PECB Code of Ethics |
| PECB Certified ISO 13485 Senior Lead Implementer | Pass the PECB ISO 13485Lead Implementer Exam or equivalent | 10 years (7 years in Medical Devices Quality Management) | 1,000 hours | Sign the PECB Code of Ethics |
Note: Individuals with both Lead Implementer and Lead Auditor credentials are eligible for the PECB Master Credential if they complete four additional Foundation Exams relevant to this scheme. For more details, contact us
Implementation Activities
To be valid, the implementation activities should include:
- Drafting an MDQMS plan
- Initiating an MDQMS implementation
- Conducting and managing an MDQMS
- Monitoring an MDQMS implementation
- Performing continual improvement measures
General Information
- Certification and Exam Fees: Included in the course fee
- Training Materials: Comprehensive manual with over 450 pages of information and examples
- Continuing Professional Development (CPD): Course completion worth 31 CPD credits
- Exam Retake: One free retake within 12 months of the first attempt
Achieving the ISO13485 Lead Implementer certification proves your expertise in implementing and managing an effective MDQMS, positioning you to improve medical device quality and safety.
