Medical Device Classes Explained: What They Mean for Regulatory Approval

Medical Device Classes Explained: What They Mean for Regulatory Approval Wouldn’t you want to be sure that the pacemaker being implanted in your chest is held to a higher standard than the bandage covering your incision? So would we. Fortunately, the Food and Drug Administration (FDA), the leading authority in the U.S. medical device market, […]

A Look at the Medical Device Approval Process

A Look at the Medical Device Approval Process There is a lot more that goes into manufacturing medical devices than simply designing or prototyping. The entire process to bring a new medical device to market can take anywhere between 3 – 7 years. While most of that time includes discovery, iterations, prototyping and testing, undergoing […]