So I want to compare the regulatory process it takes to write software for a medical device compared to a voting machine. A thread:
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Replying to @EmilyGorcenski
Consider a pulse oximeter, one of those clippy things they put on your finger at the hospital to measure your pulse.
3 replies 26 retweets 51 likes -
Replying to @EmilyGorcenski
To write software for this device you have to: - Maintain a complete design history file - Perform a traceability analysis ...
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Replying to @EmilyGorcenski
- perform a risk analysis such as FMEA - perform a cybersecurity analysis - generate a maintenance plan for updates ...
1 reply 24 retweets 55 likes -
Replying to @EmilyGorcenski
- maintain a device history record, linking serial numbers to versions - establish reporting protocols for failures ...
1 reply 23 retweets 55 likes -
Replying to @EmilyGorcenski
- notify the FDA for any bugs that affect a patient - document every software decision, who made it, and when it was made, in the DMR - etc
1 reply 24 retweets 54 likes -
Replying to @EmilyGorcenski
Now, here is the complete regulatory process for a voting machine:
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Replying to @EmilyGorcenski
That's it. Nothing. No mandatory code reviews. No cybersecurity analysis. No versioning reqs. Absolutely nothing.
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Replying to @EmilyGorcenski
sadly code reviews are not mandatory for all medical software. Process compliance and history is what FDA focus on.
1 reply 0 retweets 1 like
It depends on the device classification, level of concern, and whether the device is cGMP exempt, yeah. It's complicated. /shrug
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