Quality Assurance (QA) is a framework for ensuring the quality of products and services through a systematic approach. Medical device QA is the systematic approach implemented to ensure that medical devices are of uniform and high quality throughout their lifecycle....
A medical device blog is an informational website or a section within a website dedicated to sharing information, insights, and updates specifically related to medical devices. A medical device industry news website is an online platform that focuses on providing the...
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...
