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Biomedical Devices

1095

Assessment of cytotoxicity, skin and oral irritation of medical devices with hydrating properties: A case study

Ensuring the biocompatibility of medical devices (MDs) is essential for regulatory compliance and user safety. Under the evolving requirements of the European Medical Device Regulation (EU MDR 2017/745), products that come into contact with mucosal surfaces – such as those intended for oral use – must be supported by robust biocompatibility data. This study evaluated […]
1053

Development of Sensitive In Vitro Protocols for the Biocompatibility Testing of Medical Devices and Pharmaceuticals Intended for Contact with the Eyes: Acute Irritation and Phototoxicity Assessment

This study introduces a novel in vitro methodology that employs the 3-D reconstructed tissue model, EpiOcular, to assess the irritation and phototoxicity potential of medical devices and drugs in contact with the eye. Our study evaluated diverse test materials, including medical devices, ophthalmological solutions and an experimental drug (cemtirestat), for their potential to cause eye […]