The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling ...

Medical device makers must balance PFAS performance benefits with health risks, preparing for regulation by auditing ...

There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical ...

Sensor-based digital health technologies (sDHTs), including wearables, have great potential in the management of mental health conditions like anxiety, depression, and psychosis. Patient-centered ...

We are sure you are aware that the EU medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the ...

Medical device labeling must show many elements, such as manufacturer information, product information, intended use, indications for use, instructions for use, information regarding sterile ...

Eurofins Medical Device Services’ San Jose, CA, Ethylene Oxide (EO) sterilization site provides high-quality, fast-turnaround contract sterilization and validation services for the medical device ...

The medical technology sector in Europe is undergoing significant regulatory transformations, particularly in Switzerland and the U.K. These changes are shaping how medical devices are approved, ...

A major European contract manufacturing organization (CMO) producing diverse biologic drugs recognized the significant impact of the August 2023 EU GMP Annex 1 revision. This update, focused on ...

To gain U.S. Food and Drug Administration (FDA) approval and be first to market in the United States, a startup with a novel Class III mitral valve repair therapy needed to first fine-tune some of the ...