FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

Researchers at the Yale School of Medicine have found that the Food and Drug Administration’s De Novo pathway — a process of making risk-based evaluations of certain medical devices — has cleared ...

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 ...

ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced ...

As important as innovations in medical device technology are to improving patient outcomes, the effectiveness of these new tools is difficult to gauge. A new report recommends the formation of a ...

STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the availability of its robust In Vitro Micronucleus Test service to meet the ...

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 ...

"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...

WALDWICK, N.J.--(BUSINESS WIRE)--NextPhase Medical Devices LLC, a leading provider of electronic manufacturing services (EMS) and single-use disposable devices to leading medical device OEMs, recently ...