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...
The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing in vitro diagnostic medical devices for human use and their accessories on the market. The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro...
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of multiple regulatory authorities. Audits are conducted by Auditing...
To sell and market your medical device across the European Union (EU), you must have a CE marking of conformity. Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market must adhere to regulatory...
The complete documentation about the manufacturing and tracking of every medical device that your company sells is contained in a Device History Record (DHR). As per current international regulatory guidelines, your medical device company must maintain DHRs (or...
As a medical device manufacturer planning to sell your devices in the European Union (EU) market, you will first need to demonstrate compliance with EU regulatory requirements. You will ascertain this conformity by preparing meticulous information about the design,...
![CE Marking for Medical Devices [Step-by-Step Guide]](https://www.simplerqms.com/wp-content/uploads/2022/11/ce-marking-eu-illustration.svg)
