Using Rational Unified Process for Medical Device Software

[QUALITYTRAINER]

Does anyone have any experience with using the Rational Unified Process (RUP) for the development of medical device software and are there any quality system regulations (US or EU) that present barriers to its use? I'm assuming there aren't and the regulatory requirements would just be considered as design inputs and RUP provides adequate design control, traceability, records etc....., but I just wanted to see if I was missing something.

Any thoughts would be greatly appreciated!

[Bill Pflanz]

I don't have a lot of personal experience with RUP and especially not for software medical devices but I understand its intent. RUP was acquired by IBM last year. It is as much a document control and change control system as anything else. You can use it to record your user requirements, track change management requests, record defects and corrective action and trace the problems back through the development process.

It requires expensive licences, training, dedicated administrators and a lot of policies and procedures to fully implement its use. It also requires management committment in the same way that ISO 9000 does. Without it, RUP will just become a sink hole for money. Properly used it could provide a way to improve your software development system.

Hope this helps.

Bill Pflanz

[QUALITYTRAINER]

Bill,

Thanks for your feedback. The successful implementation of many of these types of initiatives depends on solid management commitment and I tested that a little by showing your response to the head of our business (who happened to be sitting in my office).

[Bill Pflanz]

In Reply to Parent Post by QUALITYTRAINER

Bill,

Thanks for your feedback. The successful implementation of many of these types of initiatives depends on solid management commitment and I tested that a little by showing your response to the head of our business (who happened to be sitting in my office).

So what happened? You don't say that you were shown the door so does that mean that management is going to go with RUP, with it totally supported and you are going to be a hero? Let us hear the rest of the story.

Bill Pflanz