A Short Guide to ISO 10993 Biological Evaluation of Medical Devices | Aims, Challenges and Top Tips

ISO 10993 Biological Evaluation of Medical Devices lays out a set of principles to minimise the risk of the materials used in a device.
We interviewed Jeremy Tinkler who is Director of Regulatory Consultancy and Quality Assurance for ICON Plc. In the video interview, Jeremy provides answers to the following questions:
-What does the ISO 10993 standard do or aim to do?
-What are the main challenges and common mistakes?
-How has the standard changed recently? What does this mean for device manufacturers?
-Does following the standard to the letter result in a compliant product?
#medicaldevices #biocompatibility #educolifesciences