Hi all,
As I'm new in the field of class I products I'd like to ask your opinion on:
Does a >medical device data system class I exempt< need a human factors Validation as summative evaluation?
In IEC 62366-1, it's written that "... a manufacturer shall perform a summative evaluation of each hazard-related use scenario selected ...".
In case, there is no scenario where a use error could lead to serious harm has a scenario with related risk of severity marginal to be included instead?
If there's no unacceptable risk identified, does a summative evaluation to be performed anyway to prove that the device is effective for the intended users, uses and use environments?
Or is a usability assessment sufficient?
Thanks in advance for your answers.
Tilly
As I'm new in the field of class I products I'd like to ask your opinion on:
Does a >medical device data system class I exempt< need a human factors Validation as summative evaluation?
In IEC 62366-1, it's written that "... a manufacturer shall perform a summative evaluation of each hazard-related use scenario selected ...".
In case, there is no scenario where a use error could lead to serious harm has a scenario with related risk of severity marginal to be included instead?
If there's no unacceptable risk identified, does a summative evaluation to be performed anyway to prove that the device is effective for the intended users, uses and use environments?
Or is a usability assessment sufficient?
Thanks in advance for your answers.
Tilly