Quality Function Deployment (QFD) for Design Controls
This white paper covers the history and evolution of quality systems and their application to medical devices.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Successful Practices for Battery Powered Medical Devices
This document provides successful practices for the development, manufacture, and use of batteries in medical device applications
FDA Response Letter to AdvaMed®’s UDI Cross Reference Proposal
FDA sent this letter in response to issues AdvaMed® raised to the FDA regarding implementation of the UDI rule.