ST. CLOUD, Minn., Sept. 10, 2020 /PRNewswire/ -- Offering a comprehensive portfolio of SARS-CoV-2 molecular QC standards, Microbiologics is launching IVD Process Controls and Inactivated Whole Virus ...

In the quest to cut costs and optimize operations, healthcare organizations are increasingly turning to business and engineering strategies such as Six Sigma, Lean, and the Toyota Production System.

On July 9, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA significantly affects both pharmaceutical and device manufacturers. It has a ...

On January 5, the US Food and Drug Administration (FDA) issued a new draft Guidance on Investigational IVDs Used in Clinical Investigations of Therapeutic Products. Based on concerns that drug ...

TUCSON, Ariz.--(BUSINESS WIRE)--NANOPEC, a leading provider of advanced materials next-gen bio-processing and healthcare products, today announced MetaFluorex™, a new class of ceramic films designed ...

In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases ...