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...
QMS software validation is the process of ensuring that a Quality Management System (QMS) software application is fit for its intended purpose. Quality system software validation is a requirement when the software is used to manage regulated processes in Life Science...
