Medical Device
NEW
Sterile Barrier Integrity Testing for Medical Device Systems
Sterile barrier systems are designed to maintain the sterility of medical devices throughout storage, transport, and handling until the point of use. The performance of the sterile barrier system directly influences product safety, packaging reliability, and the ability to present the device aseptically within the clinical environment.
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
