Category: News & Blog

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...

FDA Cleared

Would your Non-Device Software FAIL an FDA Audit?

Are you at Risk of Non-Compliance…? How do you know if you’re not compliant? What we’ve observed. Because we provide QMS Support to Biotech, Pharma & Medical Device companies, we’ve observed an increase in...