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Industry Standards for Medical Software User Guides

Hello, all!

My name is Barry and I'm the Director of Technical Communication for a mid-sized (but steadily growing) software company that primarily focuses on medical-related applications such as PACS, RIS, etc.  Over the last few years the company has grown as we have acquired other similar companies, and it has been an ongoing challenge to reconcile the manner in which user documentation is promulgated to the end users.  Some applications had user guides that were printed out and delivered in person to the customers.  Some applications had user guides in PDF format that were either available from within the applications via a "help" button or delivered in some other way such as on a CD or via the Web. Some applications exclusively used HTML help within the application.  And some applications relied primarily on video tutorials.  My mission right now is to figure out what the "best" way is going forward for all the various applications we now have (assuming there is some sort of one-size-fits-all solution).

I am aware of various trends regarding software documentation in general (online knowledge bases, user forums, the Wiki model, etc.), but I haven't been able to find out much about what the current trends are specifically with regard to medical software and medical devices.  I'm assuming that medical software would not necessarily follow the same trends as software in general, partially because of FDA regulations and partly because there's a bit of a difference between software you use to, say, create a graphic and one that could potentially kill somebody if used incorrectly.

I'm sorry if this is too broad of a topic, but I'd really like to hear from other people who create documentation for medical software and find out how your user manuals are delivered to the end users.  I'm not asking about the tools you use, simply how the customers access the information.

Thank you!
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