Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.

Using Your 510(k) Submission for Design
Controls and DHF Table

On the scale of possible faux pas made in medical device development, needing to retroactively create design controls and a design history file rate well up the list of no-nos. If you’re in this situation though, it’s not too late to do something about getting your house in order.