Why it’s so important to have an FDA approved Process… Here is the Million Dollar Question – how important is it to have an established process & follow it? When we are asked to...
Why does it always take longer than expected, and who’s supposed to execute…? We conducted a survey of Biotech Industry Engineering Executives, and we asked them to list the Top 5 Challenges they’ve faced...
The FDA, believe it or not, actually wants to help you deliver a mobile medical device to the market – and in our experience supporting clients with their pre-market submissions, we’ve seen multiple examples...
Every decade or so, there’s a new technology, protocol or standard that really makes a dent in the universe, and WPA3 is one of them. We’ve been writing about Cyberattacks on Medical Devices lately,...
Do it Right or do it over and over and over again… If you look around the Internet, you’ll see a ton of good-to-great Medical Device FDA Submittal advice – and it’s certainly worth...
