General Discussion on any topic relating to CPAP and/or Sleep Apnea.
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snork1
- Posts: 888
- Joined: Thu Apr 28, 2005 9:36 pm
- Location: Kirkland WA
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by snork1 » Fri Jul 28, 2006 12:34 pm
MaskedMechanic wrote:Since when does the Food and Drug Administration control software? Software is now a controlled medical device? I am reluctant to believe that software is really controlled by FDA.
I am back working in the medical devices field, and even though I am a mechanical engineer, I am very aware of the FDA involvment in software verification.
Yes indeed the FDA controls software for medical devices. In fact software verification for the FDA is one of the most difficult parts of product development these days.
Although you wouldn't know it by the sloppy interfaces in CPAP software. But at least its SUPPOSED to be accurate.....even if its incomprehensible at times.
Saying they can't sell this monitoring software to individuals due to the FDA is a reach though.
Remember:
What you read above is only one data point based on one person's opinion.
I am not a doctor, nor do I even play one on TV.
Your mileage may vary.
Follow ANY advice or opinions at your own risk.
Not everything you read is true.
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Goofproof
- Posts: 16087
- Joined: Mon Dec 05, 2005 3:16 pm
- Location: Central Indiana, USA
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by Goofproof » Fri Jul 28, 2006 2:45 pm
sthnreb wrote: I assume they purchase it lots cheaper in volume and who knows, would Respironics lie??
I don't know I wasn't close enough to see their lips move! Jim
Use data to optimize your xPAP treatment!
"The art of medicine consists in amusing the patient while nature cures the disease." Voltaire
