In the advent of the 'Refuse to Accept Policy' under section 524B of Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is motivating medical device manufacturers to secure their supply chain. The adoption of software bills of materials as stated in the ISA/IEC 62443 series of standards can help identify and manage security risks. This is where InfiniTech, an experienced Managed IT Services provider, can assist in centralizing and managing these crucial measures.

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