The usability of medical devices is a crucial aspect that impacts effectiveness, safety, and overall user experience. Usability factors are closely related to risk management and must be considered during the entire medical device life cycle to ensure that the devices are safe, intuitive, easy to use for all different kinds of users throughout its lifetime.
Overall, putting effort in usability engineering in the design and development of medical devices is essential for optimizing their clinical utility and minimizing use errors to ultimately improve patient outcomes. Regulatory bodies, such as the FDA in the United States and the European National Authorities, require manufacturers to actively work on, and demonstrate, the usability of its devices, where showing compliance with usability engineering standards is an obvious and natural part of the regulatory compliance process.
The international usability engineering standard IEC 62366-1 specifies the process for the manufacturer to analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process supports the manufacturer to assess and mitigate risks associated with use errors during normal use. QAdvis actively participates in further development of IEC 62366-1 through international and national standardization workgroups.
QAdvis offering related to Usability engineering includes open trainings, as well as trainings tailored to your organization. It also includes any other kind of support in building up and maintaining a Usability engineering file for your medical device.
Risk Management | Software and Cybersecurity | Marketing approval for medical devices, MD and IVD
Clinical evaluation and Performance evaluation | Biocompatibility assessment | Quality Management System for medical device manufacturers
PMS – Post Market Surveillance | Due Diligence | Usability | Acccess the European Union (EU) | Acccess the UK
