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

In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

Fueled by convenience, fashion, size and technical innovation, medical devices have evolved from clinical settings to daily consumer use. Today’s highly personalized devices are being embedded into ...

The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation ...

The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone, 30 new devices were approved by the US Food and Drug ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...