Achieve 510(k) Notification
Success for Device Software
Hazard Analysis? Level of Concern? Verification and validation? Labelling? What do these terms have to do with software?
Absolutely nothing . . . . unless the software is going to be part of a medical device. And if that’s the case, they’re every bit as important as any code in the software itself.
But how do you know if your software is a medical device in the eyes of the FDA and requires a 510(k) premarket notification? For instance, not all software used in a health care setting is a device.
And if your software is a regulated device, how do you know if the software requires a complete 510(k) or if it is eligible special 510(k) or abbreviated 510(k), both of which have much easier requirements to satisfy.
Achieve 510(k) Notification Success for Device Software, the new management report from FDAnews, has your answers. This report will walk you expertly through the steps you need to take to move your notification forward as quickly as possible, and without any extra work on your part. You'll learn answers to key questions, such as:
What makes your software a medical device?
How do you define and support Level of Concern (LOC) determination?
What are the 11 software-related documentation sections you must include in your notification?
When are mobile medical apps considered devices?
How do you meet labeling requirements (since there is no place to physically attach a label)?
And much more
Achieve 510(k) Notification Success for Device Software includes an invaluable checklist to help you ensure that the software section of the 510(k) is complete and easy to review.
Put an end now to the frustration of spending endless hours completing your 510(k) only to find that your submission has been rejected and you're back to square one.
Take the guesswork out of your 510(k) device software notification process with Achieve 510(k) Notification Success for Device Software.
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Table of Contents
510(k) Notification for Device Software
Understanding Level of Concern
11 Important Pieces of Documentation
Checklist for a Traditional 510(k) for a Software Device
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