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.
Regulatory Strategy and Pre-Sub
We build the regulatory strategy, write the Pre-Submission, and prepare you for the FDA meeting.
GuidanceRegulatory
This FDA guidance explains the regulatory approach and policy for multiple function device products, which are products that contain at least one device function and at least on...
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I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.
Richard Clark
Executive in Residence at Washington University
