How much will cost to build a microcontroller by experts?

[Zagan] I used to work for a US company that made a computerized periodontal probing device for measuring pocket depth and recession/hyperplasia (gum disease). Because we made a medical device the FDA was all over us forcing us to abide by FDA requirements. This included a whole list of procedures and records we had to keep to satisfy the FDA. If we didn't do this, the FDA had the power to shut us down.

I would assume that any medical device would be subject to similar requirements if marketed in the US, no matter what country the manufacturer was located. Typically, foreign products are marketed in the US by US distributors. My guess would be that the FDA would require certain procedures be followed to allow distribution in the US. Although the FDA has no direct control over foreign manufactures, they do have control over what is allowed to be marketed in the US.

// Jim

Yes, very true.

But by now I hope we all realize Robin is exercising his usual off-beat British humor (hey, I love BBC America, so I go for this stuff). I don't think anyone is really thinking about putting out substantard products

-- medical or otherwise -- then running from the law.

One small note about the FDA: they get involved only if certain medical claims are made, or if the drug/device is dangerous in its use. A device that claims to cure cancer will come under the scrutiny of the FDA. One that promotes "vim and vigor" probably will not. This is why so many homeopathic and herbal remedies specifically disclaim that they are intended for any specific ailment.

-- Gordon Author: Constructing Robot Bases (Forthcoming) Robot Builder's Sourcebook, Robot Builder's Bonanza

[Zagan] Yes, of course.

[Zagan] Apparently my small company did fall into the scrutiny of the FDA. There was nothing particular dangerous about our product, but a mis-diagnoses by one of our users could result in legal problems if someone lost their teeth due to a mis-diagnoses. While I was there we were visited and sited for several violations. Most of this had to do with record keeping and documentation on how to produce the product. I was the programmer, and curiously the inspector considered what I did to be R&D and was not interested. I was prepared to provide a complete demo of how I did the programming and made backups, but she said that was not an issue they were interested in. I found that to be odd. The hardware worked perfectly, but it was up to the software to keep records for a given patient. The software, in my opinion, was the weakest link, but the inspector cared more about record keeping than what I was doing.

I think this is a mistake on the part of the FDA. They seemed more concerned about record keeping than the programming I did. I didn't get to complete my demo since she said that was R&D and they weren't concerned about that. Go figure.

// Jim

This should have told you a lot about what the FDA is used for.

They only wanted to know who would be libel, not how you did your job.

Remember, bureaucracy is only interested in bureaucracy not technology.

------------- Nit, "liable", not "libel", look it up!

-Steve