ISO 13485 Lead Implementer
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.
Description
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 gain the "Certified ISO 13485 Lead Implementer” Certificate. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.
About This Course
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
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, and the final exam.
Assessment
Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance.
Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
What's Included?
- Certification fees are included on the exam price
- Training material containing over 450 pages of information and practical examples will be distributed
- An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
- In case of exam failure, you can retake the exam within 12 months for free
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
Accreditation
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