FDA and EU Medical Device Labeling Requirements Training
When it comes to medical devices, the term labeling encompasses much more than a label – it refers to a set of materials and information about your device. Major regulatory bodies enforce specific requirements to ensure that medical device labeling meets certain standards, and compliance with these requirements is a legal obligation for manufacturers as long as the device is on the market. This class covers the concepts that underpin medical device labeling (usability, risk, and misbranding) and the practicalities of implementing labeling processes.