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...
Nov 1, 2023 | White Paper
In an age where technology and healthcare converge, ensuring the security of medical devices has never been more important. The year 2023 marks a significant milestone in the evolution of medical device cybersecurity as FDA unveiled its final guidance on premarket...
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...