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 ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

Disrupting the status quo can be an unpredictable, even threatening endeavor for leaders in any business. Nowhere is it more true and prevalent than in healthcare today, and in the medical device ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

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 ...