ISO 13485 Lead Implementer (PECB Certified) - Including Exam
- Course Code IS13485LI
- Duration 4 days
Course Delivery
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Course Delivery
This course is available in the following formats:
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Company Event
Event at company
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Public Classroom
Traditional Classroom Learning
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Virtual Learning
Learning that is virtual
Request this course in a different delivery format.
Course Overview
TopISO 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.
Course Schedule
TopTarget Audience
Top- 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
Course Objectives
Top- 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
Course Content
Top- 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
Course Prerequisites
TopTest Certification
TopThe “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 type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
- Certification and examination fees are included in the price of the training course
- In case of exam failure, you can retake the exam within 12 months for free
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