Want to learn how to adopt 3D design and manufacturing for custom medical devices in your organisation in an effective, safe, regulatory compliant way?
SPD-Academy are launching a new distance learning course through Cardiff Metropolitan University on quality management systems for custom medical device design. This course is perfect for those looking to use technology as an opportunity to improve patient outcomes and comply with regulations.
A quality management system that complies with internationally recognised standards applies to hospital and industry-based facilities designing and making custom implants and other medical devices. Regulatory updates place greater emphasis on rigorous quality management and tighten requirements on custom devices.
This course is delivered online through a series of accessible videos available in multiple languages. Together we will:
Critically analyse and evaluate implications for developing a quality management system within a public healthcare or industry setting.
Unpack, in depth, the requirements of clauses 1 – 6 of ISO 13485:2016, the Medical Devices Regulations (MDR), and other regulations for custom medical devices.
Gain the specific skills to interpret and implement an ISO 13485 compliant quality management system in your organisation.
Develop quality management system documentation, focussing on the design and manufacture of custom medical devices ready to use in your quality management system.
Enrolment opens on the 15th Aug. Find out more and sign up to hear about this and future courses here.