Validation of EA

[Doug Blake]

Has anyone validated EA as required by medical software standards? We are starting to use EA in earnest and agencies like the FDA require validation of all tools and processes.

[qwerty]

Just one 1-year-old post: http://www.sparxsystems.com/cgi-bin/yabb/YaBB.cgi?num=1304517621/7#7

I once was in very light touch with a FDA approval for a DMS. That was quite an issue. Would be interested in the results for EA for academical reasons.

q.

[Stefan Bolleininger]

Hi,

in the meantime i did it :-)

 ialso validated EA to be used for manufacturers for medical software/devices/pems and so on for projects up to deviceclass III and SW-risk-classification C.

Unfortunately both FDA and the European standards IEC62304 / ISO13485 don't give you and advice about the concrete walkthrough in validating any kind of tool. But it is agreed to settle on the ISO26262 (Road vehikels).

I had a large exchange with the sparx support and could get much informations about the tool by dealing with it. ( Most of the time i was bugging querty and Geert).

BTW querty: for your book about the t_testplans i got this information from sparx: "Regarding t_testplans, this table is not currently used by EA, however it may be used in a future release (we do not recommend you currently use it for any purpose)." I wanted to use it for my own wishes :-)

OK, Doug if you want some information about the validation i can give you some hints and help how you do it and not a full report. For a report the usage is too individual. Remember: Validation means evidence about doing the right thing.

Greetings

[qwerty]

Hi Stefan,
thanks for both feedbacks. I will incorporate that information about t_testplans in the book.

BTW: Instead of mis-using an EA table you better add your own table. It would be nice if Sparx could provide an API to add own tables. I remember that Paolo was also after that.

Just for curiosity: Classification C and Device Class III is almost the same as Safety Integrity Level 3?

q.

[Stefan Bolleininger]

Hi, i just downloaded the refreshed book :-)

SIL as mentioned in 61508 are not tactical within medical software/devices. I cannot give you ful informations about IEC61508 because is nearly onle work with IEC62304 sw for medical devices and well medicals are different.....  

As i know you are around at Rosenheim, maybe we can meet somehow ( i'm from nürnberg/erlangen), because this requires a much longer talk around.

[qwerty]

Hi Stefan,
thanks for the feedback. My question arose just out of curiosity but you never know when such knowledge comes handy.

Unfortunately I'm "Out of Rosenheim" (Günther indicates this town) - some 721 km according to Google Maps. But when you're near Berlin some day we might meet :-)

q.

[Doug Blake]

Thanks for all your posts.

Sethor, I would be happy to take you up on your offer of some guidelines for validation of EA. Even if its only bullet points, I am sure I would be able to fill in between the lines.

I will post my experiences back here some time, but it wont be for a couple of months at least.

DGB