Is compliance with the FDA regulations the same as conforming with ISO standards?
No. Compliance with FDA regulations goes a long way toward preparing your organization to meet the ISO quality system standard for medical devices, namely ISO 13485. However, for organizations distributing medical devices in the United States, whereas ISO conformance is voluntary, FDA regulations are law and take precedence. There are differences between the regulations and the standard that are significant enough to require independent attention. For example, ISO 13485 requires continual improvement as a formal process whereas FDA has no such requirement. These differences remain despite significant activity in North America, Europe, Japan, and other countries toward harmonizing standards and regulations governing medical devices.
