MEDICAL DEVICE COMPLAINT HANDLING 

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Minimize risk and enhance compliance for your product; ZebraSCI provides investigative testing and full medical device complaint handling programs.

The FDA defines “complaint” as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. The ISO 13485:2016 definition is very similar.</