Category: News & Blog


Would your Non-Product Software PASS an FDA Audit?

Are you at Risk of Non-Compliance…for Non-Product Software Tool Validation? How do you know if you’re fully compliant? What we’ve observed. Because we provide QMS Support to Biotech, Pharma & Medical Device companies, we’ve...


How to Prevent Problems with the FDA

Meghan Alonso interviewed Kris Kelly, CEO of Advantu, about what medical device entrepreneurs, startups and established companies can do to prevent problems with the FDA.