Ecoclean: FDA- and MDR-compliant intermediate and final cleaning of knee implants

Abstract

Due to the MDR and FDA, the medical technology industry is subject to more stringent regulations and requirements for product safety, process validation and quality management than almost any other industry. This also affects the cleaning of parts and components. To meet the regulatory challenges, an internationally active manufacturer of knee implants replaced its systems for intermediate and final cleaning with the UCMSmartLine. The ultrasonic series immersion system, which is based on standardized modules, can be configured for specific tasks and enables seamless monitoring and documentation of validated cleaning and passivation processes.

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