At Wi4 Corporation, we are experts in the IEC 62304 medical device classification system. There are distinct classes of medical devices defined in IEC 62304, each with its own unique set of requirements. Class I devices are considered low-risk and require the least amount of controls to be in place. Class II devices are considered higher-risk and require additional controls to be in place. Class III devices are considered the highest risk and require the most stringent controls to be in place.
