CHI+MED does not endorse these training courses but they are included for the benefit of other Human-Computer Interaction researchers and those working in areas related to medical device design and patient safety.
BERGO is running a training course on Medical Device Usability and IEC 62366 at the Sofitel London Gatwick Hotel on Tuesday 17 to Wednesday 18 September 2013.
” ‘Usability (or human factors) engineering’ has become a hot topic in the medical device industry. Essential requirements related to usability have been revised and escalated in Directive 2007/47/EC.
Subsequently, regulatory bodies are placing greater pressure on manufacturers to conform with usability requirements through compliance with ISO/IEC 62366:2007 Application of Usability Engineering to Medical Devices.
Further, to get premarket approval in the United States, manufacturers may need to provide a Human Factors Engineering report and must consider guidance documents such as ANSI/AAMI HE75: 2009, Human Factors Engineering – Design of Medical Devices. “