Welcome to Episode 6 of Software Tech Talks – How the Pro’s Build Reliable Products. Jan Dziewior is a highly experienced regulatory executive with over 25 years’ experience developing and expanding processes for product...
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...
Welcome to Episode 5 of Software Tech Talks – How the Pro’s Build Reliable Products. Eric DePaul is a Software Engineering Executive, with over 21 years of Quality, IV&V and Configuration Management experience in numerous...
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...
