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
By May 2020, the new European Union Medical Device Regulation (EU MDR) will be fully implemented. Medical device manufacturers now
The deadline for the official implementation of the EU Medical Device Regulation (MDR) is approaching. By May 2020, your medical
FDA Form 483 inspectional observations can be disruptive to life science organizations, causing anything from delays in time to market
The pace at which news travels nowadays makes it difficult to keep up with the latest life science industry trends.
After February 21, 2019, new FDA requirements for clinical investigations went into effect. These requirements are intended to ensure clinical
