A medical device startup is a company in its early stages of development that specializes in creating, developing, and bringing innovative medical devices to the market. These innovative medical devices can be anything from diagnostic tools and prosthetics to surgical...
The European Union Medical Device Regulation (EU MDR) categorizes medical devices into one of four classes: Class I, Class IIa, Class IIb, and Class III medical devices. The MDR medical device classification is based on the device’s potential risk of harm to...
The United States Food and Drug Administration (FDA) categorizes medical devices into three classes: Class I, Class II, or Class III. The FDA classifies medical devices based on their risk to patient safety. Examples of FDA Class I medical devices include tongue...
A medical device technical file, also known as technical documentation, is a comprehensive collection of documents that contains all the technical information about a medical device. A well-documented technical file indicates that the medical device complies with...
Medical device complaint handling refers to the systematic process by which manufacturers of medical devices receive, review, and address complaints related to their products. The medical device complaint handling process is a mandatory requirement for medical device...
A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures that a manufacturer of medical devices has in place to ensure that their products are safe and effective for their intended use. The QMS includes all aspects of design and...
