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Custom Medical Devices:
Quality Management Systems
(Module code: SCM7106)


About this course

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, in depth, 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.


  • 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.

Find out more information about this course!

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More Info


For: Medical professionals

        Personnel involved in quality assurance

Length: 12 Weeks (part time)

Capacity: 10 participants

Delivery: Online, Distance learning

Qualification: 20 credits at Masters Level


CPD: 13 verifiable CPD points


Price: £1000 +VAT

Start date: 1st October 2022

Can't make this date? Fear not, sign up to our waiting list to learn about future course dates.


Professor Dominic Eggbeer is an academic researcher, writer and presenter. His 17+ years of ground-breaking research in the field of cranio-maxillofacial custom medical device won the Queens Anniversary Prize in 2015 and continues to pave the way for global adoption of these techniques.

Dom is committed to improving health and wellbeing through the development of advanced 3D digital design engineering technologies applied to the management of acute and chronic conditions. Dom's team was accredited with ISO 13485 quality management system for custom medical devices in 2018.

Emily Parker-Bilbie.png

Emily Parker-Bilbie is a maxillofacial designer, manufacturer, and university lecturer. She is passionate about communicating complex scientific knowledge in clearly communicated educational videos. In her classes, Emily shares evidence-based techniques that allow us to apply state-of-the-art knowledge to improve our patients’ lives.

In addition to working in the commercial and academic sector, she has trained and coached professionals in custom medical device design to help them develop their computer-aided design and manufacturing skills in a methodical, up-to-date, regulatory-compliant way.

About Your Instructors