Let’s Talk About Minimising Risk

Usability engineering is another form of risk mitigation. It is an internationally-recognised practice, with a specific focus on proving the safety of your product with end-users and patients. It is the responsibility of the legal device manufacturer to prove their medical device is safe to use. Non-intuitive devices that fail to consider potential risks to the user and patient can jeopardize both user and patient safety. To market your device in Australia, the US or Europe, you need to generate evidence of safe use during your product development process. Regulatory bodies have created a number of regulations and standards to help guide medical device manufacturers in the usability engineering process. These include; 

• IEC 62366-1:2015 +AMD1:2020 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
• IEC 62366-2:2015 Medical Devices – Part 2: Guidance on the application of Usability Engineering to Medical Devices
• FDA_HF (UCM259760) – Applying Human Factors and Usability Engineering to Medical Devices – 2016
• ANSI/AAMI HE75:2009 Human factors engineering – Design of medical devices
• [strong adherence to] ISO 14971:2007