Sterilization Validation TMVR valve

A startup company wanted to perform liquid chemical sterilization validation as per ISO 14160 for their class III medical devices.

BridgeMed solutions consultant took over this project, wrote protocol in compliance with ISO 14160, and identified the labs to perform the studies, coordinated and conducted the studies necessary for this sterilization validation. Finally analyzed all the lab work sheet and wrote a report and generated binder to submit to EU notified bodies.