More Lenient Guidelines May Inadvertently Lead to a Scarcity of Consented Samples Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing ...
Medical Device Innovation Consortium Releases Real-World Evidence Framework for In Vitro Diagnostics
ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics ...
RALEIGH, N.C.--(BUSINESS WIRE)--Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced today that it has acquired an ...
insights from industryLaura NeaVP of Quality and Regulatory ManagementTecan In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the ...
Laura Nea, Vice President of Quality & Regulatory Management at Tecan (Männedorf, Switzerland), discusses the benefits and challenges of transitioning to in vitro diagnostic regulation (IVDR) and ...
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...
Illumina seems to be crossing all its t's and dotting all its i's when it comes to compliance with the new IVDR regulations in Europe. The company recently issued a press release announcing that it ...
Modern medical practice and healthcare management are impossible without the vital role played by in vitro diagnostics (IVDs). They simplify the process of capturing, analyzing, and ultimately ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results