One of the most significant growth challenges facing medical device manufacturers is improving supply chain control. This struggle spans across QA/RA, production and product development teams. For operations, today’s volatile demand chain is forcing medical device and other life science companies to gain additional visibility into supplier qualification, selection and communication. For the supplier quality team, the FDA has increased its inspection focus on purchasing controls. And worldwide, many global regulators require companies to control supply chain procurement, surveillance, manufacturing and product distribution. Beyond the regulatory challenges are other factors that are making the supply chain more complex, such as supplier diversity. FDA and global regulators are focused on device manufacturers’ control of their supply chains. You will want to avoid receiving 483 warning letters that are being issued to medical device registrants for deficiencies against CFR 820.50.