From implants to prosthetics, technology has enabled the fabrication of increasingly complex life changing custom medical devices.  But every medical device, big or small, has potential impact on safety—so it is vital that our quality-assurance process is robust. Developing this process will allow you to make safer devices that are aligned with both organisational practices and medical regulations.

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This accredited, Master’s level short course by the International Academy of Surgical and Prosthetic Design at Cardiff Metropolitan University is aimed at specialists involved in designing and fabricating custom maxillofacial implants and prostheses. It aims to deliver the expertise required for organisations to develop their own quality management system that supports safe practice and regulatory compliance.

 

Together, we will study:

 

• 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

 

• Information on complying with regulations and standards

 

• Guided tutorials for creating your quality management system

 

• Learning consolidation assessments with personalised feedback

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Included:

 

• Templates you can use within your quality management system

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• 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.