Biological Risk Assessment for Medical Devices
The biological risk assessment (BRA) is a crucial component in ensuring the safety of medical devices that come into direct…
ISO 10993-7: Ensuring Safe Limits for Ethylene Oxide Residues
ISO 10993-7 plays a crucial role in ensuring the safety of medical devices sterilized using ethylene oxide (EO). This standard…
Hemocompatibility of Medical Devices: an Overview
Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with…
ISO 10993 Cytotoxicity Evaluation of Medical Devices
The evaluation of the cytotoxicity of a medical device based on ISO 10993 is one of the key milestone for…