Do you need to submit the documentation of your medical device software to the FDA or an European notified body?
Perhapbs you're overwhelmed by all the medical device regulations?
Or do you want to make sure you'll quickly pass FDA approval or CE-marking process?
This SSRS *) checklist will help you to:
Easily prepare your medical device software documentation for FDA submissions and CE approvals.
Using a checklist like this can help you save money and time by eliminating unnecessary iterations, re-submissions and other redundent and superfluous tasks.
*) SSRS: Software System Requirements Specificiation