Welcome to our accredited, Master’s level short course on custom medical device design. In this course, we will explore the intricacies of designing custom devices that meet the highest standards of quality and safety, as well as the manufacturing methods that make these devices a reality.

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One of the key topics we will cover is Clause 7 of ISO 13485. This standard is the international quality management system for medical devices and is critical to ensuring that your device meets all necessary safety and performance requirements. We will delve into the specifics of this standard and show you how to apply it to your own device design.

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We also provide guided tutorials that demonstrate how to design maxillofacial devices including orbital floor plates, cranioplasty plates, complex osteotomy cases and fibula free flaps. These tutorials will cover everything from the initial concept phase to the final implant design, with a focus on considerations for manufacturing methods. You will learn how to select the right materials, user centred design, and optimize your device for cost-effective production.

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Our course is designed for specialists involved in designing and fabricating custom implants and prostheses. Whether you are new to the field or have years of experience, this course will provide you with the tools and knowledge you need to create custom medical devices that meet the highest standards of quality and safety.

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Enrol today and start designing custom medical devices that make a difference in the lives of patients.

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Together, we will study:

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• A series of lectures covering clause 7 of ISO 13485:2016, segmentation of medical scan data, 3D computer aided design of custom implants, materials, and manufacturing methods.

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• Dedicated one-on-one expert coaching with Professor Dominic Eggbeer and Emily Parker-Bilbie, supplemented with healthcare specialist input.

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• Information on complying with regulations and standards.

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• Guided tutorials for custom medical device design.

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• Learning consolidation assessments with personalised feedback

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Included:

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• 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.

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• 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.

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