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.
Proper Medical device complaint handling management is key to complying with regulatory requirements not only in the US, but around the world as well. In the EU, MEDDEV 2.12/1 outlines post-market surveillance activities for proper incident investigation and CAPA handling.
ZebraSCI’s medical device complaint handling services provide an effective and simple way of facilitating the management of your product complaints, leaving you free to concentrate on bringing new products to market. Our programs are designed around the structured and time-sensitive processing of your returns. By conducting the original technical investigation and feeding data back to you rapidly, we enable you to provide a fast response to your end-users and react to technical failure trends early on.