Marc,
Haven't been online for quite some time now, but signed on to find your post. The company I'm working for (MED-EL) is one of the three manufacturer worldwide, who manufacturers a medical device, a cochlear implant, and software is developed for the outside processor to the device.
I have only performed manual testing to the software (system testing), but would like to introduce some automation. Being new to the medical field and being new to automation in software testing, I need to know what the FDA accepts and would isn't allowed?
For any hints or comments, I'd be much obliged!
Sincerely, Renate Strina
SQA, Software Testing
www.medel.com
[email protected]