Medical Devices
According to World Health Organization (WHO), medical device is defined as an instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
The biocompatibility evaluation of your medical device is a mandatory part of the conformity assessment and has an array of standards on testing, identification and quantification of degradation products, and other general biological evaluation of medical devices.
Our biocompatibility tests are coordinated according to ISO 10993, determining the biological risks of medical devices and product-specific standards, whereas the selection of applicable tests is device-dependent.
Some of our services:
- Creation and design of the Risk Assessment Plan: Biological evaluations of medical devices are risk management activities and therefore they must have a Risk Assessment Plan designed in advance according to ISO 10993-1.
- Evaluation of in vitro cytotoxicity: Based on ISO10993-5, we offer the in vitro cytotoxicity evaluation of medical devices, incubating cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. This method is designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
- In vitro sensitization and irritation assessment: Based on ISO 10993- 10, we offer in vitro sensitization and irritation evaluation for medical devices and their constituent materials with regard to their potential to induce skin sensitization and irritation, through New Approach Methodologies (NAMs).