Nov 14, 2023 | White Paper
With updates and guidance getting published constantly, it can be difficult to keep up with everything regulatory bodies come out with. On top of that, determining what is applicable to a specific device can be even more difficult. This White Paper discusses...
Oct 12, 2023 | White Paper
It can be hard to keep up with FDA’s latest regulatory intelligence, trust us, we know! When we say STOP, save these 3 guidance documents and sign up for FDA’s webinar please listen. Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
Aug 14, 2023 | White Paper
Are you equipped with a cutting-edge tool for advancing medical device development? Whether you’re currently utilizing such a tool or crafting one, the recently unveiled definitive version of the “Qualification of Medical Device Development Tools” guidance holds the...
Jun 26, 2023 | White Paper
You NEED the FDA eSTAR Quick Guide! Who remembers when Microsoft Office first came out? Everyone was learning and an Excel or Word laminated cheat sheet could be bought at the grocery store to help with the learning curve. This eSTAR White Paper has a similar intent,...
