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ISO 13485 Lead Implementer
Duration
5 Days
Course
PECB-ISO13485LI
Available Formats
Classroom Training, Online Training
Course Description
Overview
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.
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
General Information:
- Certification and examination fees are included in the price of the training course
- Training material containing over 450 pages of information and practical examples will be distributed
- An attestation of course completion worth 31 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
Objectives
By the end of this training course, students will be able to:
- 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
Audience
- 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
Prerequisites
-
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Topics
- Day 1: Introduction to ISO 13485 and initiation of a MDQMS5
- 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
- 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
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Self-Paced Training Info
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- Same in-demand topics as instructor-led public and private classes.
- Standalone learning or supplemental reinforcement.
- e-Learning content varies by course and technology.
- View the Self-Paced version of this outline and what is included in the SPVC course.
- Learn more about e-Learning
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Please take a moment to fill out this form. We will get back to you as soon as possible.
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