Good day Liao,
There are a few ways that usability can be determined for a medical device. I would refer you to the FDA guidance document as there is a lot of helpful information there: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices and of course IEC 62366-1. To answer your question, no it does not need to be done onsite. There could be a "simulated" environment where the product can be used by individuals who "represent" the user of a device. It really depends on what you need or want to achieve from the usability testing, but this does not necessarily have to be done onsite at a hospital or clinic.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 14-Sep-2023 03:56
From: Ronald Boumans
Subject: Usability evaluation procedure for Surgical medical device
You should start with analysing use risks and eliminate, reduce or mitigate those risks as far as possible. Next, you can do a use simulation, where a potential is asked to use the device in a test situation. This should confirm the results of the risk analysis. Depending on these results and remaining risk, you may want to add studies with observers in real use situations as part of the PMCF plan.
------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 13-Sep-2023 20:52
From: Liao Emily
Subject: Usability evaluation procedure for Surgical medical device
Could anyone suggest how to perform a usability evaluation for surgical medical devices, such as Surgical Rulers?
Because the intended user and the applying place are surgeon and operating room, respectively, is it necessary for an observer to be on the site? Is there any other way to record the testing?
------------------------------
Liao Emily
Jhongli
Taiwan
------------------------------