Live instructor-led training
ISO 13485 Lead Implementer Training
- CMDBID 100191356
- Course Code
- Duration 5 Days
Scroll
Course content
What you will learn
Overview
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.
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.
Skills Gained
- 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.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Outline
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
Certification
The "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.
Continue your learning pathway: view all Quality and Management courses or compare related courses and follow-on options.
Talk to an expert
Thinking about Onsite?
If you need training for 3 or more people, you should ask us about onsite training. Putting aside the obvious location benefit, content can be customised to better meet your business objectives and more can be covered than in a public classroom. It's a cost-effective option. One-to-one training can be delivered too, at reasonable rates.
Submit an enquiry from any page on this site and let us know you are interested in the requirements box, or simply mention it when we contact you.
All $ prices are in USD unless it’s a NZ or AU date
SPVC = Self Paced Virtual Class
LVC = Live Virtual Class
Please note: All courses are available as Live Virtual Classes
Trusted by over 1/2 million students in 15 countries
Our clients have included prestigious national organisations such as Oxford University Press, multi-national private corporations such as JP Morgan and HSBC, as well as public sector institutions such as the Department of Defence and the Department of Health.
