Unfortunately for you, I don't. I stay far away from the regulatory stuff - I really only enough to get my job done, mostly in the form of directives from my manager and our quality section.
That said, our software development process is really just a mild adaption of all our other development processes (like ones we use for hardware and reagent development). As I've described it above, it's a pretty standard engineering approach to design control, and there are all sorts of variations on them.
In fact, the FDA makes note of how broad the field of medical devices are, and does not actually enforce any specific design control process, but rather provides a framework for you to develop a process that meets your developmental and regulatory needs. As part of getting FDA approval, your design control process will be audited, as well as how well you followed it. In addition, medical devices are classified into 3 classes, corresponding to patient risk. Our product is currently classified in the lowest risk level, and so we can avoid a lot of additional requirements. As I recall from skimming through the standard (sorry, we only had a hard copy at work.. costs money apparently), higher risk devices with software components must have certain types of tests performed. In our risk class, we have total freedom to define our testing requirements - that said, the rigour of our testing is still under FDA scrutiny, it just means that there are no specific checkboxes to hit (like integration testing for example).
That said, our software development process is really just a mild adaption of all our other development processes (like ones we use for hardware and reagent development). As I've described it above, it's a pretty standard engineering approach to design control, and there are all sorts of variations on them.
In fact, the FDA makes note of how broad the field of medical devices are, and does not actually enforce any specific design control process, but rather provides a framework for you to develop a process that meets your developmental and regulatory needs. As part of getting FDA approval, your design control process will be audited, as well as how well you followed it. In addition, medical devices are classified into 3 classes, corresponding to patient risk. Our product is currently classified in the lowest risk level, and so we can avoid a lot of additional requirements. As I recall from skimming through the standard (sorry, we only had a hard copy at work.. costs money apparently), higher risk devices with software components must have certain types of tests performed. In our risk class, we have total freedom to define our testing requirements - that said, the rigour of our testing is still under FDA scrutiny, it just means that there are no specific checkboxes to hit (like integration testing for example).
I guess if you want a place to start off, this might be a good place to look: http://en.wikipedia.org/wiki/Design_controls