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 medical device life cycle to ensure that the devices are safe, intuitive, easy to use, and meet the needs of healthcare professionals and patients.
Overall, prioritizing usability in the design and development of medical devices is essential for maximizing their clinical utility, minimizing user errors, and ultimately improving patient outcomes. Regulatory bodies, such as the FDA in the United States and the European Authorities, require manufacturers to demonstrate usability testing and compliance with usability standards as part of the regulatory approval process.
The usability standard ISO 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 permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use.
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
