These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

Discover how medical 3D printing creates patient-specific devices and custom prosthetics. Read our guide to clinical ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

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 ...

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 ...

It’s been over 15 years, but the advent of Apple’s iPhone still represents one of the biggest paradigm shifts in the world of consumer technology. It fused style with substance; form with ...

Among the mechanical components that go into the design of the world’s two million different kinds of medical devices, consider the motor to be an unsung hero. Embedded inside a medical device, the ...

When it comes to medical device design—a broad category that includes a range of different machines performing countless critical functions—the stakes are high. Because no matter the application, ...

The US Food and Drug Administration (FDA) last November sent a letter to Texas-based Mibo Medical Group to say that the firm addressed the violations in a warning letter from December 2018. "Future ...