Webinar On Demand: Designing for Safety – How to Build Safer, More Usable Medical Devices
Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of
Medical devices are becoming more complex, more connected, and increasingly used in home settings by people with varying levels of
If you missed our recent panel discussion, “From Concept to Compliance: Navigating Risk and Regulatory Submissions Across the Life Sciences,”
In the medical device industry, where precision and compliance are paramount, staying ahead of regulatory changes is critical. With FDA
September 2019 saw the release of several final guidance documents relating to 510(k) submissions. One of the most utilized pathways
In September 2019, FDA released final guidance on its Special 510(k) Program. This optional pathway allows medical device manufacturers a
