FDA and Outsourcing

Outsourcing seems to be a popular topic these days for medical device companies. There are publications devoted to the topic. Outsourcing certainly has its place.

A recent post at MD&DI reminds readers that FDA regulations apply to outsourcing relationships. This should come as no surprise. Companies need to properly evaluate, qualify, and monitor suppliers. Typically these activities should coincide with the risk the supplier represents. The concept of outsourcing certainly isn’t new. However, many companies are outsourcing more and more. And the types of activities and services being outsourced today are activities and services that a company would have held tightly just a few years ago.

An established medical device company likely is aware of supplier and purchasing controls and associated regulations. Chances are these companies have quality procedures in place too. Just realize that the more third parties are utilized, the more robust these systems need to be.