Establishing Proper Validation of Extruded Silicone Tubing

Medical device manufacturers understand that contract manufacturers are experts in their manufacturing discipline. That said, as medical device OEMs respond to the current requirements described in the European Medical Device Regulation (EU MDR) or by the Food and Drug Adminstration (FDA), the topic of process validation is more and more common. Most OEMs simply don’t have a validation plan for a contract manufacturer to follow. While engineers are fully aware that it’s a requirement for releasing their product in the market, many simply want to “check the box” that this has been completed. This article presents a program that moves projects from the process development phase of manufacturing to a fully validated process.1, 2