If you’re working on creating documents for your 510(k) submission, but you don’t know where to start, we can help.
If you’ve begun working on software for a medical device (or you’ve nearly completed it), and you need help creating the documents for your 510(k) submission, you’ve come to the right place. Most regulatory consultants are not software engineers, thus, although they can provide some high-level guidance regarding the documents you’ll need to write, they won’t be able to help with the details.
Our teams combined software engineering and regulatory expertise enables us to help more directly.
We provide three levels of support, depending on your budget and needs: