So, what has medical device design to do with a thousand year old game?
Well, you might have all the pieces ready for your medical device to work but due to increasing burden of regulations it is more and more difficult to document your design.
For example look at the design below. Cut it along the lines and get 7 pieces of information. Think of the 7 pieces as:
- risk management,
- user requirements,
- system requirements,
- software requirements,
- software design,
- test results.
Now try to re-establish the traceability, meaning to put together a square for the CE certification. If you manage to do that, spell the letters F, D, or A with the same pieces because the FDA might want to see the same information in a slightly different way.
If you think it’s easy do it first ask your colleagues to do it and than imagine the same game with thousands of pieces of information which need to be linked to get the documents for certification.
You like it hard?