IEC EN 62366 Usability Retroactive Compliance

D

Dquestion

#1
Per EN 62366 Usability, there are generally two processes defined within the standard:

1) The integration of Usability within the Risk Management Process, which is incorporated with the application of ISO 14971

2) The integration of Usability in the Design and Development process.

When you "implement" EN 62366 and develop a Usability Engineering process in your Quality Management System, you should do both.

For #1 above:
Adding Usability risks to the Risk Management process and related Risk Management documents (Hazard Analysis, PFMEA, DFMEA, etc) isn't too hard and is recommended through other threads.

For #2 above:
Per EN 62366 section 5.5 a Usability Specification must be developed which includes testable requirements. (guidance suggests Usability Goals)

Then each of the Usabilty Specifications must be verified/validated (section 5.8 & 5.9).

For new Product Development activities, creating and incorporating Usability Specifications and Verifying/Validating them isn't a problem.

But, for Devices that are already on the market, what is a manufacturer supposed to do to comply with the requriement for developing Usability Specifications and Verifying/Validating them?

Is a manufacturer supposed to create new Usability Specifications for the "old" devices and conduct Verification and Validation studies to comply?

Or can you develop Usability Specifications and use post market data (stating that there are no incidents to invalidate the specification) as the verification/validation of the Usability Specification?

Please suggest methods of compliace if I haven't touched on a particular approach.

Thank you for your input.

D.
 
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Marcelo

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#2
It dependes on what you need to comply with. If you need to comply with IEC 62366 (which does not seem to be the case) you need to use the usability engineering process as defined by the standard.

If you need to comply with usability aspects in general, a definition and use of post-market data might be enough (i would talk with your regulator to make it clear, thought).
 
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