Medical Device Software Validation Guidance

I recently was asked to be a part of the Quality Assurance "Taskforce" at the medical manufacturing company that I work for. Specifically, I was asked to be the lead on software validation. I am new to Quality Assurance and software validation and on top of that know next to nothing about software and validating it. I have been reading through General Principles of Software Validation; Final Guidance for Industry and FDA Staff. I was wondering if anyone had some ideas of other literature I could read to try to learn more about the validation requirements/process, as well as learn about software in general. Any input would be greatly appreciated!! Thanks!

~Asimo

How much do you understand about software development? Validation is (far) more than running just a bunch of tests. IEC 62304 is a pretty concise description of the process but it's for medical devices and might be confusing on the classes (safety levels) if you don't fully understand. The SEI CMM is a great guide but the maturity levels might be difficult to grasp without understanding of the processes.

Not sure if that's all that helpful but there are a couple of resources.

The other angle on this subject for me is that the device manufacturer already should have something that addresses this question in its QMS ...
I would advise this book actually to have a read of it, I quite like it.
http://www.amazon.co.uk/Software-Ve...PE/ref=sr_1_15?ie=UTF8&qid=1360320570&sr=8-15
Cheers!

Thank you both for responding and for the information. The biggest issue for me is that I know very little about software and writing programs in general, which makes learning how to validate it fairly difficult. I will take a look at the resources you have both listed. Hopefully I will be able to glean a little bit of knowledge from them. Thanks again!

~Asimo