Contact Us

One Way to Speed Up Software 510(k) Submissions

 February 07, 2023
 J. David Giese
SHARE ON

We talk through a strategy for speeding up 510(k) submissions by using a letter to file for certain features that wouldn't trigger the need for another 510(k). The amount of work done by the software engineering team should be the same (or higher) using this approach, but you can submit sooner, which can be a win if you have funding milestones or conferences deadlines tied to the submission.

SHARE ON
×

Get To Market Faster

Weekly Medtech Tips

Our weekly Medtech tips will help you get safe and effective Medtech software on the market quickly. We cover regulatory process, AI/ML, software, cybersecurity, interoperability and more.