Category: News & Blog

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.

medical device software development

What is your Top 10 List for Passing an FDA Audit?

Is your team preparing for an audit…possibly caused by excessive CAPA’s? I know (we) engineering types don’t always appreciate guidance the quality folks share with us – particularly regarding compliance best practices – but...

SDLC Process Improvement

Why FDA Compliance (knowledge) Matters

Is your software engineering vendor helping or hurting you? When you are reviewing the myriad software engineering vendors out there, as part of your due diligence – for your own sanity, make sure you...