Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers ...

IVDs are defined in the new EU IVDR legislation as: “Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

James Hamerslag reflects on his long tenure at Siemens Healthineers, the evolution of packaging and automation in medical ...

Responses were filtered so that only those working full-time for a manufacturer of medical devices, a manufacturer of in vitro diagnostics (IVDs), or a manufacturer of both medical devices and IVDs ...

Surmodics operates via two reportable segments — Medical Device and IVD. In the reported quarter, sales in the Medical Device segment were $23.3 million, down 1.1% from the year-ago quarter.

Such medical device organisations can be involved ... and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016. He has over 15 years ...

"BD business separation could allow competitors to rise in IVD test markets" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site ...

sero reactive blood bags from blood centres as a raw material for preparing in vitro diagnostic (IVD) reagents. Also Read | Medical devices maker Poly Medicure to focus on exports amid ...