Quality Management System
Quality Management System is a formal process used to review the operations, products and services of a business, with the goal to identify areas that may require quality improvement. Quality Management Systems are required in all areas of business activity, regardless of the size of the institution.
In order to be compliant to various regulatory and customer requirements and to design and manage all relevant processes the Department of Cardiovascular Engineering has defined and established an QMS which is tailored to the needs of university research facilities and industry. 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 fulfilment 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.