Developing Software for regulated industries

[ASTDan]

Hello,

I am looking to do business with more medical companies, and I want to learn more about developing software for regulated industries. I have been directed to FDA 21 part 820.

This is great however I am looking for more resources.

-Is there a class/seminar that someone would recommend that helps with understanding jargon, methodologies, process, etc. for developing software for regulated industries (i.e. FDA 101)

-Is there any good books, websites, articles , etc that you found useful.

-Would anyone be willing to share there journey to develop code for regulated industries and some of the pitfalls associated with it.

-What tools have you found useful in developing code (i.e. NI requirements gateway)

Thanks

Dan

[PaulG.]

QUOTE (ASTDan @ May 7 2009, 10:19 AM)

-Would anyone be willing to share there journey to develop code for regulated industries and some of the pitfalls associated with it.

Not mine personally, but http://www.cs.tau.ac.il/~nachumd/verify/horror.html' rel='nofollow' target="_blank">highly recommended reading.

[crelf]

QUOTE (ASTDan @ May 7 2009, 10:19 AM)

I am looking to do business with more medical companies, and I want to learn more about developing software for regulated industries.

There are a lot of standards that you could (and maybe should) read through, but until you really know the business that you'll be working in then it's difficult to suggest one or two generic docs for you to read. In my experience, the absolute most efficient way to learn this stuff is to work alongside someone who has experience in the regulated industry and the company (different companies use difference processes, and then in turn different implementations of those processes). Sorry that's not the answer you wanted to hear, but that's how I see it.

[ASTDan]

QUOTE

In my experience, the absolute most efficient way to learn this stuff is to work alongside someone who has experience in the regulated industry and the company (different companies use difference processes, and then in turn different implementations of those processes).

I hear you about working along somebody. However I want to get some basic knowledge under by belt so when I connect with that person I am not wasting a lot of time on fundamental stuff. Is that best served by reading regulations or is there some other resource i.e. "regs for dummies/engineers"

QUOTE

Sorry that's not the answer you wanted to hear, but that's how I see it.

Well put on some rose colored glasses and then talk to me. :thumbup:

[crelf]

QUOTE (ASTDan @ May 8 2009, 02:09 PM)

Well put on some rose colored glasses and then talk to me. :thumbup:

The glasses are twice as big as they need to be

[Lars915]

In my business, we deal with a lot of regulations including military, aviation, and safety critical systems. I don't believe there is any single source to tell you how to deal with "regulated industries", there's just too much variation. As stated above, determine what regulations apply to you, then start digging into the specifics of those regulations. One of the first questions to ask is whether or not your product is even regulated. Medical will have many layers of criticality. User interfaces are treated much differently than software that actually controls a blood conditioning machine for instance.

Every industry has experts that will help you through the maze for a price.

[ASTDan]

I just wanted to share where I am at on this journey.

This seems to be a great start!

http://www.fda.gov/cdrh/comp/guidance/938.html

I have also stumbled across an organization that seems to be focused on helping professionals maintain regulatory compliance withing the medical domain.

http://www.ispe.org/