Design Controls for Medical Devices and IVDs

In addition to providing an in-depth discussion of contemporary design and development principles and practices (and corresponding EU and FDA regulatory requirements), this approximately four-hour, self-paced course explores the essential relationships between risk management and design and development throughout the lifecycle of a medical device.

This course is designed for risk management professionals, engineers, quality and regulatory professionals, and others engaged in design and development throughout the lifecycle of a medical device, as well as those managing risk management and design and development of medical devices.