The Federal Drug Administration’s current cybersecurity requirements are not appropriate for addressing and avoiding medical ...

Remaining competitive in the medical device market requires the ability to improve quality while reducing costs. Sartorius offers various solutions to improve productivity and meet rigorous compliance ...

Flexible heaters are used in a wide range of medical and diagnostic devices. They play a crucial role in thermal control for applications such as nebulizers, respiratory humidifiers, blood analyzers, ...

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA ...

Steute's wireless transmitter-receiver module is designed to control foot and hand switches in medical device applications. As foot and hand controls become increasingly prevalent in doctors' offices ...

Customer requirements and regulatory classifications are driving increasingly rigorous quality control protocols in medical device thermoforming, with cleanroom manufacturing emerging as the gold ...