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The latest FDA Guidance on Cybersecurity requires that we show how we secure our device's software supply chain. Next time someone complains, I'm going to remin
by HeyLaughingBoy 2y ago
The latest FDA Guidance on Cybersecurity requires that we show how we secure our device's software supply chain. Next time someone complains, I'm going to remind them of this attack.
- lenerdenator 2y agoAnd the person complaining will say "unless you can guarantee a greater than 50% chance of that happening in the period we're budgeting for, we're not going to bother with all of that work."
- JumpCrisscross 2y ago> the person complaining will say "unless you can guarantee a greater than 50% chance of that happening in the period we're budgeting for, we're not going to bother with all of that work" If you've worked at a medical-device manufacturer, please blow a whistle. That isn't normal and could seriously hurt people. The reason it isn't a broad issue is the cost of approval revocation, or even suspension, is existential for many companies.