Two Questions about Medical Device Software

#1
Hi everyone,

Two questions:

1. In the guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", is the Software Environment Description the same as the Software Maintenance Plan prescribed by IEC 62604?

2. Where does the UDI go on the software, when it doesn't have physical media. It's a downloadable app. Does the UDI placement depend on its level of concern?


Thanks. Any help would be appreciated.
 
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yodon

Staff member
Super Moderator
#2
1. No, the Software Environment Description is what's described in 62304 5.8.5. This would be your compilers / IDEs, build scripts, etc. Ideally, several years later, you can re-build the software exactly as built when released. (Yes, that's an ideal and rather challenging given impact from OS changes, etc. but that's the idea).

2. My understanding is that this (UDI information) would be available on the splash screen and/or in a 'help' or 'about' page for GUI-based software. I'm really not completely sure, though.
 

DEVigil

Involved In Discussions
#3
1. Yodon cites the correct section of 62304 above. The maintenance plan section you were asking about is for the product itself after it is released.

When we filed our most recent 510(k), for this section we had introductory language briefly describing our development process, software design controls, life cycle, source control, configuration management, change control, and coding standards (some of which were necessarily also alluded to in other appropriate sections of the submission). We attached copies of the policies/procedures/etc. that weren't already presented elsewhere in the submission (in our case, the coding conventions for the languages in which the product was developed).

2. Like you, we do not have physical media and the product is installed electronically. We have the UDI in plain text displayed in the Help About screen.
 
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