Biocompatibility evaluation according to ISO 10993-1 is one of the most important validation activities for medical device. It is an important process during the design of the device that has a fundamental impact in the regulatory clearance or approval of the device by regulatory agencies or notified bodies.
Specifically, in this WhitePaper prepared by QualityMedDev, there is an in depth overview of one of the most important process for biocompatibility evaluation according to ISO 10993-1: the biological risk assessment (BRA).
Furthermore, the BRA is the process of evaluating the device and the related manufacturing from biological risks point of view. It can be considered a part of the risk management process.
The outcome of the risk assessment is the evaluation of which endpoints shall be used for the evaluation of the biocompatibility of the device.
In fact, the biocompatibility testing strictly depends from the type of the device, from the type of contact between the device and the patient and the duration of this contact.
You can refer to the WhitePaper below for more information.
In conclusion, the biocompatibility evaluation of medical devices is en essential step nowadays for quality and regulatory experts and in general for the quality management system.
WhitePaper : Biocompatibility Evaluation for Medical Devices
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