Who is also dealing with the FDA as s/w developer?

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Jorg
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Who is also dealing with the FDA as s/w developer?

Post by Jorg » Fri Mar 24, 2006 2:05 pm

Hi everybody,

After 40 hours of intensive training plus exam I know now how FDA regulations work, and what the overhead is of paper I have to write to create a medical application. We develop class II medical devices, and FDA requires us (by law) to follow quality regulation 820 (amongst others).

I was just curious, who else here on the board has to deal with the FDA? We are a european branch to a US company but since we ship to the USA we have to adhere to FDA.

I have to say this course was amongst one of the toughest given. Now I know at least I do not want to become a quality engineer .. sheesh ..

I was absent for a week (well mostly) but now the course finished so I'll be around more...

- Jorgen
Forensic Software Engineer
Netherlands Forensic Insitute
http://english.forensischinstituut.nl/
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rubdeela
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Re: Who is also dealing with the FDA as s/w developer?

Post by rubdeela » Tue Jul 26, 2011 5:38 am

What are the steps to apply for FDA approval to produce and sell food preservatives? I have a company in another country but want to apply for FDA approval to produce and sell our canned food preservative in the U.S.

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