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...
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...
Practical Implications for Manufacturers – Conformance with the IVDR is a significant business challenge that must be overcome – don’t be late! In order to enjoy continued access to the EU Market – medical...
This is not something we like to hear – is the Agency tasked with Patient Safety hiding critical defects from Public View? Per a report by Kaiser Health News, a Doctor performing a routine...
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...
