Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment.  This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version used for so many years.  This checklist can be helpful for internal audits, supplier audits, training,...Read More

A committee draft (CD) of “IEC TR 62366-2: Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” was issued for comment. This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Mary Decareau of SoftwareCPR prepared a tiered checklist for EN 62366 Medical devices – Application of usability engineering to medical devices for our internal use and we are making it available to paid subscribers at the link provided and...Read More

A proposal has been made for a fast-track amendment to IEC 62366 related to use with legacy products. Application of “62366 Medical devices – Application of usability engineering to medical devices” to legacy devices has been inconsistent and problematic; this proposal is for a fast track amendment to address what is called User Interface of...Read More