A Brief Overview of FDA Medical Device Regulations — Part 2
Welcome back to the final entry of our two-part overview of FDA regulations for medical devices! In the first part of our series, we covered medical device classifications and listings, establishment registrations, premarket notifications, and premarket approvals. In case you need a quick review, you can check it out here. We’ve got a lot of […]
A Brief Overview of FDA Medical Device Regulations — Part 1
To develop, manufacture, and distribute health tech devices in the United States, innovators must have a thorough understanding of regulations and compliances. In the first entry of this two-part series, we provide a brief overview of the first few FDA regulations for medical devices. A Necessity for Safe Innovation Any technological innovation or advancement in […]
New mHealth Apps Can Deduce What Ails You
It wasn’t too long ago that the concept of MedTech app development would have baffled both mobile app developers and medical professionals. The thought that technology could enable doctors to accurately diagnose a malady would have been met with laughter. But now, that’s exactly what’s happening. Developing a Mobile Hot Spot Detector Diabetes patients often get […]