Medical Device
Medical Device Biological Evaluation Plan
At Medistri, we aim to address these issues by using a scientifically sound risk-based approach to determine the most appropriate testing methods for each device. That’s why we follow the guidelines outlined in ISO 10993–1:2018 and the FDA’s guidance document on the use of this standard, which require a structured biological evaluation plan as part of a risk management process in accordance with ISO 14971
