Comment Re: The book is VERY poorly written. (Score 1) 30
Perhaps. But itâ(TM)s at 4.8 stars with 14 reviews on Amazon, so apparently there are many connoisseurs of poor writing out there. Or... ?
Perhaps. But itâ(TM)s at 4.8 stars with 14 reviews on Amazon, so apparently there are many connoisseurs of poor writing out there. Or... ?
The FDA doesn't actually do testing. The device maker supplies evidence that development followed a process that includes testing, the types and amounts of testing being based on the risks posted by the device.
A company can potentially lie, and claim they did testing that they didn't - but Goddess help you if FDA figures that out: you're in deep, deep trouble. And they can definitely figure it out during a regular inspection, or if people get injured by your product, etc.
Sorry to quibble... but medical devices are normally developed using a process that conforms to ISO 13485, not 9001. Pretty similar, though.
I'm working with some other folks to start a company to develop, manufacture, and market open-source medical devices. We all have extensive experience in developing commercial medical devices - defibrillators, radiation therapy for tumors, etc - and we're convinced that getting more eyeballs to review software and hardware will substantially increase safety and reduce costs.
Yes, we know how to work with the FDA and so forth.
Stay tuned...
It turns out that in managing batteries and booting there are a ton of oddball cases that cause things like this to happen. For example, there may be enough power available from the battery to start the boot process with the CPU in a low power, but once some peripherals start turning on the power draw bec omes more than the battery can support, a voltage rail drops to low, and a reboot happens. Shameless plug: there's a chapter in my book on product development that covers some of these issues and solutions, http://www.goodreads.com/book/...
I had Ubuntu running on our main home computer for more than a year. There were definitely some annoyances, but things were tolerable. Until I upgraded Ubuntu (I forget which version) and sound was broken hard - I spent hours fixing it, but got calls from home every few days asking me to "help fix the sound. it's broken again". Finally, I gave up and switched back to Windows.
It works and docs find it helpful. I'm amazed that it's ignored in TFA.
Docs won't use EMRs until they need to do so to get paid. That's the long and the short of it.
A formal parsing algorithm should not always be used. -- D. Gries