Software in Medical Devices, by MD101 Consulting

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Where do these templates come from?

Perhaps some of you who download my templates wonder how I managed to write them or where they come from.
This is a long story. Once upon a time in 1940’s, Bell Labs scientists John Bardeen, Walter Brattain and William Schockley invented the transistor.
Well, huh, not so long!

The templates documents I gathered in the templates repository page stem from the standards of the US Department of Defense (DoD). The DOD issued a first standard about software development cycle in the late 1980’s called DOD 2167A.
It was superseded by MIL-STD-498 in mid 1990’s. This is the standard I used to write most of the templates about software development. Templates are a translation of Data Items Descriptions (DID) found in MIL-STD-498.
You will find the standard if you search in the DAU website. It’s a PDF version pretty difficult to read! DID are also present in various locations on the net. If you want to look at the SRS DID (the one that gave the SRS template), type « SRS-DID.PDF » in your favorite search engine and you’ll find it easily.
Today, MIL-STD-498 is superseded by IEEE 12207, a much broader - and commercial - standard. MIL-STD-498 is about one fourth of IEEE 12207 content. MIL-STD-498 is only about software development (a product standard) whereas IEEE 12207 covers much more aspects of the organization of a software company (a process standard).
A good part of IEC 62304 comes from IEEE 12207. Here we are! MIL-STD-498, IEEE 12207 and IEC 62304 our favorite standard! IEC 62304 is also a process standard. Thus to cover IEC 62304, you need a quality system with standard operation procedures and some more templates that are not inspired of MIL-STD-498 DIDs. This is the case especially for risk management, problems resolution and software maintenance.

Now you know everything about these templates. You will be able to impress your friends when you have dinners in town! :-)

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