There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success.

Watch a comprehensive overview of regulatory requirements and testing standards relevant to disinfectant and cleaning validation in pharmaceutical and medical manufacturing. It begins with a ...

Sensor-based digital health technologies (sDHTs), including wearables, have great potential in the management of mental ...

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 ...

Explore the critical aspects of ophthalmic drug and device testing, emphasizing regulatory and patient compliance. It highlights the importance of ensuring safety, efficacy, and adherence to stringent ...

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, ...

If you are in the medical device development industry, and selling your own devices, you likely know you need a quality management system (QMS). A QMS helps ensure that manufactured devices meet all ...

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 ...