PEMS Documentation for Medical Device Software - Requirements




For one of our medical device we are having two software's, one is pc based software which is used to view the measurements and another which is the firmware for the device.

My doubt is whether we need to follow PEMS documentation as per IEC 62304 for both the software for only for the firmware?

Please help.

Thank you


Welcome to the forums Sara,

I would suggest that you do need to follow 62304 for both parts.

However, you may be able to classify them separately. So it might be possible to, say, classify the PC software as 'Class A' whilst the firmware is Class B. This would reduce your paperwork requirements.

This would depend upon how the 2 parts interact, the actual medical purpose of the device and how much confidence can be gained from the verification process.


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I would agree with Pads38 that you most likely have follow the standard for both.


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The direct answer is that if you have a medical device then you should follow 62304. The risk analysis will determine what classification applies to the software. This classification can be determined for each "Software Item" which can be any grouping of code including the code for each processor.

It's possible to not follow 62304 at all and instead show that your processes and practices have resulted in a product of appropriate quality. It will most likely be easier to just follow 62304 and use the classification of Software Items that it allows to determine what quality practices are done for each processor.
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