Quality Management & Regulatory Affairs
The working group Quality Management (QM) and Regulatory Affairs is establishing a Quality Management System (QMS) in the Department of Cardiovascular Engineering (CVE). Our QMS serves the purpose of designing and managing relevant processes. Initially, our main focus is on the key process of development.
A "safe" product is always a basic requirement. Particularly in Medical Technology comprehensive regulatory requirements exist for "placing medical devices on the market and operating them". Since these requirements affect almost all aspects of product realization, we focus on them at an early stage – during the development process of medical devices. The systematic fulfillment of regulatory requirements is to be regarded as part of QM. For example, the risks for patients, users and third parties can be minimized through consequent risk management.
Besides establishing a QM-System in the entire Department of Cardiovascular Engineering (CVE), the QM team is currently assisting in the following major projects: