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We are regularly asked about marking medical devices ranging from surgical tools, instruments and even implants. The following note explains factors that you need to consider when specifying CerMark as a marking solution.  FDA Approval A common question is “do your products have FDA approval?”  CerMark is a coating used in a marking process.  FDA approval must be obtained by each medical device manufacture where the process of marking would be considered part of the items manufacturing process.  The CerMark coating and marking process otherwise generically referred to as “laser bonding” is not something the FDA can approve by its’...

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