Thank you for your interest in this accredited, Master’s level Custom Medical Devices short course by the International Academy of Surgical and Prosthetic Design at Cardiff Metropolitan University.

The course provides maxillofacial departments with the expertise in addressing the Medical Devices Regulations requirement of an ISO 13485 Quality Management System for custom medical devices.

You will receive:

• 13 lectures covering clauses 1 – 6 of ISO 13485:2016, the Medical Devices Regulations (MDR), and other regulations for custom medical devices.

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

• Expanded up-to-date 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

• 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.

The above video is a preview of one of the lectures included in the course.

On completion of this lecture, you should be able to:

• Explain what custom medical device design is.

• Summarise the use of medical imaging scans, such as computer tomography (CT) data and their role in custom medical device design.

• Explore the potential benefits and limitations of custom medical devices.

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