NQA ISO 13485 (Medical Devices) Introduction and Implementation Training
Gain insight into the application of ISO 13485:2016 as the basis for a Quality Management System used by medical device manufacturers.
The aim of this course is to provide delegates with knowledge of the requirements of the ISO 13485:2016 standard, discussing key principles and concepts as well as how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulations.
Delegates will gain the knowledge to be able to understand, develop, implement and maintain ISO 13485:2016 management system.
What will I learn?
- How to understand and describe the purpose and intent of a quality management system in the context of medical devices.
- How to summarise the contribution that ISO 13485:2016 can make towards the development of safe, effective and compliance medical devices.
- How to state the structure, key points, aims and objectives of the ISO 13485 standard.
Is this course right for me?
This course is aimed at:
- Anyone involved in the implementation / operation of the standard
- Senior Management, Quality Managers, Regulatory / Compliance Managers
Book your place above or contact us at firstname.lastname@example.org.
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Telephone: 0800 052 2424