ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical laboratory. ISO 15189 may be consider the analogue of ISO

An electronic case report form (eCRF) serves as a fundamental tool in the collection of data for clinical studies and research participants. It functions as a digital questionnaire that captures

According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or

Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your medical devices and to your quality management system, in order

Analytical performance for in-vitro diagnostic device is one of the main factor that need to be taken in consideration before placing an IVD device on the market. According to IVDR