Software for Medical Devices - Requirements Content for compliance with IEC 62304

C

cwilburn

Starting to get Involved
Hi Everyone!

My company develops software for medical devices and I am updating our processes and templates for compliance with IEC 62304.

Section 5.2.2 Software Requirements Content contains some requirements type that we don't typically include in our SRS (software requirements specification) but that wouldn't hurt to add. There are, however, some other types that I am not sure about. Can anyone provide examples or an explanation of "requirements related to methods of operation and maintenance" and "user maintenance requirements"?

Thanks so much!
Cathy
 
M

Mark Meer

Trusted Information Resource
cwilburn said:
Can anyone provide examples or an explanation of "requirements related to methods of operation and maintenance" and "user maintenance requirements"?
Click to expand...

Does your device require maintenance?

Some things to consider (for example):

1. Is the software intended to be updated? Can users check for and install patches/updates themselves? This might be considered maintenance.

2. Does the software keep data that requires periodic backup? This might also be considered as maintenance.

3. Does the software implement some function that is tied to device maintenance? For example, a device might need periodic re-calibration, and perhaps the software implements the interface through which the device can be calibrated.

Just some examples I can think of with respect to software and maintenance..

MM.
 
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