Intermediate and final cleaning process for knee implants in compliance with FDA and MDR regulations
MDR and the FDA have imposed regulations and requirements governing product safety, process validation and quality management on the medical device sector that are stricter than in almost any other industry.
This also affects cleaning processes for parts and components. To meet regulatory challenges, an international manufacturer of knee implants has replaced its intermediate and final cleaning equipment with the UCMSmartLine. The ultrasonic multi-chamber immersion cleaning system, which is based on standardized modules, can be individually configured for specific tasks, and enables validated cleaning and passivation processes to be seamlessly monitored and documented.