An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
The ISO 13485:2016 standard specifies requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Such medical device organisations can be involved in one or more stages of the life-cycle, including; design and development, production, storage and distribution, installation, or servicing of a medical device, and design and development or provision of associated activities such as technical support.
ISO 13485:2016 can also be used by suppliers or external parties that provide products, including QMS-related services to such organisations.
This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.
This course will be useful as a refresher or for those new to the medical device industry.
Upcoming start dates
Suitability - Who should attend?
Benefits of Attending
- Understand the requirements of ISO 13485
- Learn how to develop a Quality Management System (QMS)
- Know your responsibilities
- Comply with the regulatory requirements
- Take part in workshop exercises to consolidate the knowledge gained
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