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Medical device Usability

It is also called as Human Factor engineering as it deals with the application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve sufficient usability.
Usability engineering deals with the 3 important factors like user, user interface and use environment associated either with the safe and effective use or unsafe and ineffective use of the medical device.

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Medical device usability testing

Performing Usability testing in medical devices helps the manufacturer to assess and mitigate risks associated with actual and incorrect use due to user errors.
Usability of medical devices defined as the characteristic of user interface which facilitates the use and establish the effectiveness, efficiency and user satisfaction in the intended use environment.

Application for grant of permission to conduct clinical investigatio

Usability engineering process helps manufacturer in identifying hazards and hazard related to user and user interface, applying and evaluating the risk control measures related to user interface which further provides safety to patient or user.

Following are the process involved in usability engineering

  • Prepare use specification
  • Identifying device primary operating function
  • Identify known or foreseeable hazards and hazardous situations
  • Identifying hazard related use scenarios
  • Select hazard related use scenarios for summative evaluation
  • Establish user interface specification
  • Establish user interface evaluation plan
  • Perform user interface design, implementation and formative evaluation
  • Perform summative evaluation of the usability of the user interface

Manufacturer who wants to be complied with EN 62366-1:2015 for user interfaces if medical devices which has been commercialized prior to 2015 i.e. prior to establishing the usability standard, those device comes under user interface of unknown provenance (UOUP).

If any design changes in the presence of UOUP, then manufacturer shall follow all activities of EN 62366-1:2015 for changed parts of the medical device.

FAQ:

Usability engineering helps the manufacturer to assess and mitigate the usability related risks associated with the medical devices. Usability engineering helps to make sure that the user interface of medical devices can be handled by the user without any risks if used correctly.

IEC 62366-1:2015 is a standard for performing usability testing for medical devices and EN 62366-1:2015 is the harmonised standard for the same.

UOUP is abbreviated as use interface of unknown provenance. Medical device user interface which was commercialized prior to the publishing of usability standard can also comply with EN 62366-1:2015 to show up their device is safe & effective. Here manufacturer can perform a subset of activities of EN 62366-1:2015 to comply.

Steps mentioned in EN 62366-1:2015 for UOUP,

  • Prepare use specification
  • Review post-production information
  • Review hazard and hazardous situations related to usability
  • Verifying the risk control measures applied for the risk and its acceptable level
  • Residual risk evaluation

The output of these mentioned activities documented both in risk and usability file.

Following are the process involved in usability engineering

  • Prepare use specification
  • Identifying device primary operating function
  • Identify known or foreseeable hazards and hazardous situations
  • Identifying hazard related use scenarios
  • Select hazard related use scenarios for summative evaluation
  • Establish user interface specification
  • Establish user interface evaluation plan
  • Perform user interface design, implementation and formative evaluation
  • Perform summative evaluation of the USABILITY of the user interface

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