Author: Kris Kelly

Rock the FDA Audit – by establishing a Great QMS!

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...


Medical Device Delivery Issues

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...