The UK’s Regulatory Agency MHRA has just published its Human Factors and Usability Engineering – Guidance for Medical Devices including Drug-device Combination Products. The guidance states that it is intended for “manufacturers of all device classes and developers of medical devices and drug-device combination products, and notified bodies responsible for assuring the quality of those […]
One team left at the weekend for nine days formative testing in New Jersey, starting today. The study will be testing the usability of safety syringes and auto-injectors to deliver a new medication. Five different users group have been recruited to take part including patients, caregivers and Healthcare Professionals.
Medical Device Usability (MDU) is pleased to be sponsoring this year’s Essential Human Factors Gala Dinner at the Hilton Hotel, Cambridge on 8 November 2017. The Gala Dinner takes place on the second evening of the course, which runs from 7-9 November 2017. The course will be taught this year by Dr Bob North and […]
Whilst everyone is keen to get the latest medical devices out on the market as soon as they have been approved by the regulators, this enthusiasm can be costly if the device isn’t ready for usability testing and the study has to be delayed too close to the original date, thus incurring costs from venues […]