Supplier Quality Agreements 101: What, Who, And Why?

By David Butcher, MasterControl

Medical device and pharmaceutical manufacturers are ultimately responsible for the products they make and sell, even if they outsource some or all of their manufacturing or other operations. To ensure that products are safe and meet the claims made for them, the U.S. Food and Drug Administration (FDA) and other regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers.

Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.