U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
Reduce risk and control your label, its design, and the data.
Part three of the design verification series discusses in detail the steps that should be taken during testing.
Prior to design verification of packaged products, consider the following process-related elements.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
As with other aspects of medical device design, medical packaging has its own unique set of challenges. Taking a big step back and reconsidering our assumptions can help us make the kind of impact necessary to ensure our future.