It all started when my boss came in and said "ok folks... we are about to go to FDA and ask them to approve the device we have been working on... so get all your ducks in a row... and prepare the set of documents for submitting to FDA"
We had consultants with experience in this kind of stuff guide us from early on, and with their help we prepared the first set documents that were submitted to the FDA... But they were not satisfied with that stuff and came back with a million questions...
So for round two, boss also decided to take in help I was asked to evaluate the CDRH guidelines for FDA for software containing medical devices and the questions of the FDA and prepare an appropriate set of documents.
This blog will list my exploits as I navigate the forest of FDA Guidelines trying to figure out what they really want and why and then how to put it in place with the minimal effort.