Establishing Proper Validation of Extruded Silicone Tubing M 20 Cov edical 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 www.medicaldesignbriefs.com ToC Prior to jumping into a validation discussion, it makes sense to address the difference between verification and validation. Verification is typically performed while a product or process is being developed. It is a means by which to determine whether a product (or process) meets the dimensional or visual requirements set forth by the product specification. FDA 21 CFR part 820.75(a) stipulates that if process Medical Design Briefs, January 2022 Credit: SiMEDExhttp://www.medicaldesignbriefs.com http://info.hotims.com/82317-803