In short, if the nature and complexity of the device, in combination with the users' attributes somehow affects the usability of the device, then appropriate usability design and testing are needed. Remember that a key goal of usability design and testing is generally aimed at reducing human error. Often, such use error isn't a function of training or education, but rather is caused by biological human attributes, like size, strength, inability to see in the dark, etc.
From a more standardized/formal perspective, think about things like the fact that EN/IEC 62366-1 (as amended) for example requires the manufacturer to establish a usability engineering process to provide safety for the patient, user, and others. It defines "user" as any person interacting with (i.e., operating or handling) the device, and says that common users include clinicians. In other words, it requires proper consideration and design to accommodate the user's usability needs, even when the user is a trained clinician.
AAMI HE75 is another example of a standardized paradigm that demands design to meet the user's usability needs, even if the user is a trained clinician.
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 22-Sep-2022 14:22
From: Anonymous Member
Subject: Is Usability Testing required for IVDs?
This message was posted by a user wishing to remain anonymous
Is there anything that would make usability testing required for regulatory compliance for an IVD intended for professional use? Or is it a best practice?
Thank you in advance.