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...
When I started my career in software quality assurance and testing, I was really excited about the opportunity afforded me in a rapidly growing industry. Back in 1998 – the dot com boom was...
