medical device regulations

Medical device regulations are guidelines set by government agencies to ensure that medical devices, such as pacemakers or diabetic monitors, are safe and effective for public use. These regulations require manufacturers to conduct thorough testing and provide evidence of a device's quality and safety before it can be sold. They also involve ongoing monitoring after a device hits the market to address any issues that may arise. The goal is to protect patients and support healthcare providers by ensuring that the medical devices used are reliable and beneficial.