About this course
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.
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.
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.
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.
Enrol today and start designing custom medical devices that make a difference in the lives of patients.
Together, we will study:
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.
Dedicated one-on-one expert coaching with Professor Dominic Eggbeer and Emily Parker-Bilbie, supplemented with healthcare specialist input.
Information on complying with regulations and standards.
Guided tutorials for custom medical device design.
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.
Preview a lecture
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: £1140 +VAT
Start date: Monday 26th February 2024
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 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
Frequently Asked Questions
OverviewImporting your CT data correctly into Geomagics Freeform is an important step to avoid designs that don't fit the anatomy. It's important to understand the different options and how they will affect the patient's anatomy to produce a safe and effective design process and end result. In this video, we take a closer look at these import options and they change the patients anatomy, including: Measurement units Clay, buck and mesh models and their properties Model resolution Voxels, voids and filling holes X,Y,Z global model position
Further ReadingRelevent research paper links / citations
AttributionsCT scanner videography by RhPAP is licensed under CC BY 3.0