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

 

About this course

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.

 

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

 

Included:

 

  • 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.
 

Testimonials

"Testimonials are a great way to showcase positive feedback from others."

- John Hopkins Medical 

Timberly Williams

Next course - February 2023

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More Info

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For: Medical professionals

        Personnel involved in quality assurance

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 27th February 2023

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

Scholarships

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

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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.

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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