16. May 2022Extractable unknown substances or substances with missing toxicological dataMedical devices are often highly complex products made of different materials. About the handling of different substances.
25. April 2022AET – What is it?The AET is an essential component for the biological safety assessment of the chemical characterisation of leachable substances in medical devices. Read details about the AET here.
25. March 2022Risk management and biological safety: A powerful teamRelevant aspects of biocompatibility of the essential safety and performance requirements for medical devices from Annex I of the MDR.