Manufacturers of medical devices are required to use a process to analyse, specify, develop, and evaluate the usability of a medical device as it relates to safety. The usability engineering (human factors engineering) process defined in IEC 60601-1-6 and IEC 62366-1 permits the manufacturer to assess and mitigate risks associated with normal use.
The user interface design shall be treated as part of the overall medical device design and the risk management process defined in ISO 14971 shall be used as it inter-relates to usability.
The purpose of the usability engineering process is to provide the use-related safety of a medical device for the patient, user, and others. To achieve this purpose, the process mitigates risks caused by user interaction problems associated with normal use, such as use errors.
601 Consultancy Ltd is well equipped to guide your team and participate in the application of IEC 60601-1-6 and IEC 62366-1 together with ISO 14971 to your medical device and assist you to ensure that your user interface design meets the requirements of the standard.