As of January 2025, the UK government has provided updated guidance on the regulatory requirements for in vitro diagnostic medical...

Biomarkers have become essential tools in modern medicine, providing critical insights into disease states, treatment efficacy, and...

In medical device regulation, the adherence to stringent quality management standards is pivotal. Regulatory bodies such as the U.S. Food...

In the field of immunoassays and in vitro diagnostics (IVD), ensuring the accuracy and reliability of tests is paramount. These...