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Custom Medical Devices:
Device Design
(Module code: SCM...)


About this course

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.

This accredited, Master’s level short course by the International Academy of Surgical and Prosthetic Design at Cardiff Metropolitan University aims to provides maxillofacial departments with the expertise in addressing the Medical Devices Regulations requirement of a Quality Management System for custom medical devices.


Together, we will study:


  • 19 lectures covering clause 7 'product realisation' of ISO 13485:2016, tutorials for custom medical device design including; cranioplasty plates, orbital floors, complex craniofacial implants, fibula free-flap surgical cutting guides, medical imaging protocols, anatomical data segmentation and manufacturing methods.


  • Dedicated one-on-one expert coaching with Professor Dominic Eggbeer and Emily Parker-Bilbie


  • Information on complying with regulations and standards


  • Guided tutorials for creating your quality management system


  • Learning consolidation assessments with personalised feedback




  • Templates you can use within your quality management system

  • Resources, including all the current, relevant ISO standards, scientific papers, course workbook, and access to all Cardiff Metropolitan University's resources.


  • 20-credit Master’s level Transcript qualification and 13 verifiable CPD points

The course is online, part-time over 12 weeks, with limited spaces so that you receive a great experience with on-hand expertise.


Fully-funded scholarships are available for those working across Welsh Health Boards. Get in touch to find out more.

Launching October 2023

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For: Medical professionals

        Personnel involved in quality assurance

        Designers & Prosthetists

Length: 12 Weeks (part time)

Capacity: Limited spaces

Delivery: Online, Distance learning

Qualification: 20 credits at Masters Level


CPD: 13 verifiable CPD points


Price: £1120 +VAT

Start date: Monday 2nd October 2023

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