Before a medical device can be launched it is recommended that it go through a number of human factors and usability studies to ensure it is safe to use. These studies are used to develop safe medical devices and to ensure that they are usable by the intended users (patients, carers and healthcare professionals ect).…
DetailsI live at home with my family, a number of pets and luckily for myself and my family, very few medical devices. But as I age, I expect to be bringing home from hospitals and pharmacies more home-use medical devices – especially if hospital care is shifting towards home-based treatments and rehabilitation. This I do…
DetailsThis is a continuation of part 1 and looks at more usability requirements. Section 14.2. “Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible; a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features,…
DetailsWhilst the Medical Device Directive (MDD) had a few mentions of the word “usability”, it was not back in 1993 when it was written, a commonly used term. More often, it was the term “ergonomic” that was used, and this word did make a few appearances in the Essential Requirements (Annex I) of the 1993…
DetailsOften within organisations, the Marketing function and the Research and Development functions act collaboratively to define the opportunity space for the next product. Market research is often performed at the very front end of the development process – to define the need, quantify its purpose, return on investment, and to ensure the organisation understands what…
DetailsTraditionally, software development for medical devices focuses on machines designed specifically for a medical purpose, from portable infusion pumps to complex and large MRI scanner. Essentially, the software is programmed on a development platform, compiled and deployed to a CPU (Central Processing Unit) with the purpose of converting input commands to hardware functions. In Europe,…
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