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Want to learn how to adopt 3D design and manufacturing for custom medical devices in your organisation in an effective, safe, regulatory compliant way? Well, we want to help! This course is great for those looking to use technology as an opportunity to improve patient outcomes and comply with regulations.

Custom medical devices are made every day: from life-changing prosthetics to surgically invasive, permanent implants. But every medical device, big or small, has an impact—so it is vital that our quality-assurance process is as sound as possible. Developing this process will allow you to make safer devices and choose options that are aligned with both organisational practices and medical regulations.

Together we will:

- Critically analyse and evaluate implications for developing a quality management system within a public healthcare or industry setting.

- Unpack the requirements of clauses 1 – 6 of ISO 13485:2016, the Medical Devices Regulations (MDR), and other regulations for custom medical devices.

- Gain the specific skills to interpret and implement an ISO 13485 compliant quality management system in your organisation.

- Develop quality management system documentation, focussing on the design and manufacture of custom medical devices ready to use in your quality management system.

Included:​

- Real-life examples and templates taken from our ISO 13485:2016 certified quality management system.

- Cardiff Metropolitan University accredited course with a Masters level 20- credit Transcript upon completion.

- Professionally produced video lectures so that you can learn at your own pace. They can be viewed anywhere and anytime, day or night, and you can pause and rewatch them whenever you like.

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