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Quality Management 
For Custom Medical Device Design

Sept. 2023


This workshop will introduce participants to the essentials of setting up in-hospital quality management systems for the design and production of custom medical devices.


It is run between SPD-Academy at PDR and Swansea Bay University Health Board and is supported by regulatory experts, industry and clinical specialists. 


Custom medical devices, such as implants and surgical guides, are proven to improve patient care. Creating a quality management system is essential to creating safe and effective custom medical devices that comply with medical device regulations. 

This course will equip healthcare specialists with the knowledge and skills necessary to ensure that the medical devices they design and use are safe, effective, and of high quality. It is designed to promote discussion between disciplines and uncover practical ways to support healthcare specialists and the hospitals they work within to implement their own ISO 13485 quality management system.  

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