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,...
May 12, 2023 | White Paper
Are you in early stage development of a device or device-led combination product? The FDA has rolled out a number of initiatives over the past several years to facilitate more timely access for patients to innovative medical devices and technologies. One such...
Apr 3, 2023 | White Paper
Being in unchartered territory within a regulated space can be scary! Yet, it is in unchartered territory that new breakthrough technologies and treatments are found. The FDA Breakthrough Devices Program can alleviate some of the worry. The FDA is committed to a high...
