By By Dan Aicher, CEO, EmbedTek, LLC
Supply chain disruptions are forcing an inordinate amount of change to critical components of medical devices. The burden placed on medical device OEMs to validate these changes distracts engineering, quality, and operations teams from more strategic activities. Reacting to an unpredictable supply chain endangers new development as well as ongoing production.
Seeking partnerships with supplier organizations that have the resources, organizational discipline, and structure to help execute change validation can be part of the answer. A third-party resource, especially one already familiar with the product and OEM’s processes, would be able reduce the burden on the OEM’s internal departments giving them the opportunity to focus on more strategic projects. Following are questions to keep in mind when determining which suppliers can step up to the task.
Is the supplier well-versed in quality management system (QMS) p…