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 ...

As more and more complex medical devices are being operated at home, manufacturers need to develop them with disabled users in mind. Stephen B. Wilcox, PhD The Personel Lasette from Cell Robotics ...

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 ...

Medical devices—whether compact, in-home tools like blood pressure monitors or large, sophisticated diagnostic systems used in hospitals and laboratories—are increasingly designed for global markets.

Regulators increasingly want medical device manufacturers to begin with a more precise understanding of their product's ...

After the US requested a three-year delay to the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) last month, the European Commission (EC) released a document identifying two types ...

Instructions for medical devices are unnecessarily complex, and the federal process for these labels needs an overhaul, according to the Association for Professionals in Infection Control and ...

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 ...