Fda 510(k) Guidance
We are developing a simple device that connects a pill container to a smartphone to monitor pharmaceutical adherence. We need guidance on the 510(k) process for development of both our physical product and our software before we go to manufacturing.
John |Owner and Sr. Consultant
***** discovering another ***** of mobile technology that helps people manage ...4.7 Hours Later
Great idea. We've gotten about 30 computer / wireless software apps reviewed and cleared, plus many ...5 Hours Later
I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...5.2 Hours Later