Quality management software is a digital platform designed to automate and streamline quality management processes within a company. A Quality Management System (QMS) software helps ensure high and uniform quality of products and services in compliance with customer...
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...
M-Files is a document management software that empowers companies to manage all their information. M-Files helps manage data, regardless of type or location, within a single and intuitive interface. The M-Files software can also be used as an Electronic Quality...
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...
