Harper Brooks
Registered
My company designs and develops software that is considered a medical device.
The software can be setup on most computers (there are some performance requirements and prerequisites) - but in general, the user can just use his computer for the software.
My company also offers the service of providing a computer to use with the software (and a few other HW parts). Neither the computer nor any of the HW parts are however considered a medical device.
Do you think that we could get away with saying that section 7.4 of 13485:2016 (Purchasing) does not apply to our organizations as the only items that are purchased are these HW parts (that are not the medical device).
Or are we required to fulfill 7.4 for sold parts that are not considered a medical device?
The software can be setup on most computers (there are some performance requirements and prerequisites) - but in general, the user can just use his computer for the software.
My company also offers the service of providing a computer to use with the software (and a few other HW parts). Neither the computer nor any of the HW parts are however considered a medical device.
Do you think that we could get away with saying that section 7.4 of 13485:2016 (Purchasing) does not apply to our organizations as the only items that are purchased are these HW parts (that are not the medical device).
Or are we required to fulfill 7.4 for sold parts that are not considered a medical device?