ISO 13485 Medical Devices Quality Management Systems
Course ID IS013485LIE
Course Name ISO 13485 Lead Implementer
Language English
Training Duration 5 Days
CPD Certification (Credits) 31 CPD
Exam Duration 3 Hours
Retake Exam Yes
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Why should you attend?
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?
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
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
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
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
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
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