EA Validation for Medical SW process

[Tage Korsdal Nielsen]

Does anyone have any experience with validation of EA as required by Medical device SW process (EN 62304)?

Rgds Tage

[Stefan Bolleininger]

Hi,

I did the same now for three times :-)

IEC62304 doesn't require you to validate your software tools if you use them as tools and not as product.
IEC62304 only requires "software within products" to be validated.

However ISO13485 requires the qualified(validated) tool.

Unfortunately it is to long to declare within a forums thread, but you may give me a short mail for it.

Additional I developed a free medical-specific EA-Addin which you may download on my webpage.

Regards

Stefan  

[ChrisDr]

I also developed a model based SW architecture template that makes it simplier to fulfill the norm and we also kept EA outside of the validation process. This is not required, as mentioned, by the norm but might be dependending on your dev process requirement, which is a differnt story. I made the trick that EA was treated similar to a "drawing" tool where not the EA artifact (=the model) was reviewed, but the document created out of EA.
EA was our modeling tool and  created a virtual document template and a package structure based on IEEE 42010 with some extenstions from Rozanski / Woods together with some modeling guidelines to make the documentation of the segregation requirements straight forward, or at least as much as possible  . The resulting document was then reviewed and signed according to the process and EA never showed up as a tool which needs to be validated.
In additon we had a tracing process thas was based on the document and not on the tool so we could prove complete hazard tracing withing another (validated) tool chain.

Same as for my colleague before, full explenation would be too much for the thread. Shoot me a PM if your interested in more information

Chris

[Stefan Bolleininger]

Hi

@ChrisDr: your solutions seams to be interesting. Could you write me a E-Mail and tell more about it?  

Don't get my wrong, I didn't develop a architecture template, I developed a process :-)
I do everything for PLM completely in EA without toolbreaks or another toolset. There is no need for Polarion or others.

The Core-hint within ChrisDr's comment is the manual review which you can proceed and avoid the tooling qualification.

But there are a few catches:

• You may not use code generation withour validation.
• You need to review your traceability manually (which you really should without validation)
• You need many reviews.

The validation can avoid manual work and gives your some interessting information about your real workflow - which increases your efficiency.

To get through the validation I recommend you to use the ISO26262 "Functional safety for road vehicles" or FDA Computerized software validation as principle.

Regards

Stefan

@ChrisDr: where are you from? Maybe we should join together some day.

[Tage Korsdal Nielsen]

Thanx Stefan and ChrisDr for your feed-back.

We are using EA in the way you suggest Chris, as a drawing tool and together with EAdocx generating documentation according to our SW lifecycle process and templates, and then review these documents.

I find it a bit of a hassle to generate these documents (even with eadocs), and I think review time would be better spent using EA.

So I conclude that it is possible to validate EA for this.

But since EA is still new in our company, I would suggest to our SW QA manager to get external help if we should decide to go in this direction.

Rgds
Tage