~ Let’s stop doing the same thing over and over – expecting different results ~ Whenever I review the latest entries on the FDA Recall List, I’m still surprised when I see the Reason...
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,...
