Part 820 is wide-reaching. In order for a medical device company to fully understand what compliance with Part 820 means, further elaboration is required. Two of the most important areas this applies...
This post resumes our discussion of the FDA’s new cybersecurity guidance for medical devices surrounding the design and development of trustworthy devices.
FDA approval can be achieved in two ways: The 510(k) process, in which the manufacturer must provide evidence that the device they intend to market is “substantially equivalent” to a device already...
CFR Part 820, often referred to as simply Part 820, delineates the requirements for a quality management system that must govern the design and manufacture of any device sold in the United States....
