Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive ...

DSM Biomedical offers Medeor® Matrix Surgical Mesh with extracellular biologic for the reinforcement of soft tissue during the healing process. This non-crosslinked biologic mesh is ready to use right ...

Significant updates to ISO 18562 are here, impacting everything from risk assessments to regulatory strategy. If your FDA submissions aren't finalized by July 5, 2026, these changes will affect you.

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...