Borderline Medical Devices

Olivia SunSenior Consultant Regulatory Affairs Have you ever been unsure of whether or not the device you are working with is a medical device? Don’t worry, most of us have. Medical devices are based on a wide spectrum of technologies. In fact, there are about 2 million different kinds of medical devices on the world […]

The Importance of Understanding Medical Device Classification

Medical Device Classification

In the process of putting a medical device or an IVD product on the market, one of the first and most important steps is correctly identifying its risk classification. In a nutshell, medical device classification is a regulatory process used in categorizing medical devices based on their intended use, as well as potential risks to […]