Custom Medical Devices:
Quality Management Systems
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
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.
"This course has been beneficial to myself and my organisation. It has helped with ideas to improve our ISO13485 QMS which has now passed stage 1. Extra reading materials and templates are an very useful. Perfect times on lectures and informative."
Preview a lecture
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: £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