Fraunhofer MEVIS Project Group Image Registration in Lübeck successful qualified as manufacturer of software for medical devices
Since December 2012 the quality management system of the Fraunhofer MEVIS Project Group Image Registration in Lübeck is certified according to EN ISO 9001 and EN ISO 13485 by DEKRA Certification GmbH.
The Project Group has implemented the quality management system (QMS) to assure high diligence and safety in their core competences.
For the development of software components for medical devices the QMS ensures safety and conformity according to the above-mentioned standards for the components to be delivered - and also for their usage.
Concerning research projects the QMS serves as quality assurance and quality improvement.
The certification includes the following scopes:
* EN ISO 13485:2012 + AC:2012: Customer driven development and maintenance of medical software.
* EN ISO 9001:2008: Execution of research and development in the field of computer assistance in medical diagnosis and therapy.