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...
This is how to Identify all the High Risk areas in the Application & Logically Expose, Isolate and Mitigate Critical Defects Lurking in your Medical Device. I’m going to lay out the process I...
What would help them become more effective & productive? As a provider of software development solutions, this is an excellent question – and it’s one I’ve been asking myself for over 20 years. Today...
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.
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...
