Munich, Germany / Morristown, NJ – July 23, 2009 – Definiens, the number one Enterprise Image Intelligence® company, has successfully completed the certification process for the worldwide common quality management standards DIN EN ISO 9001:2008 and EN ISO 13485:2007.
Definiens has demonstrated that its process workflow—from design and development to production, sales, installation and customer service—is fully compliant with the regulations defined by the International and European standardization authorities. The certification audit was conducted by the Notified Body Landesgewerbeanstalt Bayern, a TÜVRheinland® company.
“Aligning the company’s structure and processes to meet the requirements of DIN EN ISO 9001:2008 certification represents a significant milestone for Definiens,” said Dr. Wolfgang Rencken, Chief Operating Officer at Definiens. “Certification provides our customers with further assurance about the quality of our processes and products, as well as increasing the efficiency of our internal workflows. Both of which will help further Definiens’ market standing.”
Along with the general requirements for quality management systems set in DIN EN ISO 9001:2008, Definiens maintains the requirements of EN DIN 13485:2007. This standard defines the quality management system requirements for Medical Devices.
“The EN ISO 13485:2007 certification enables Definiens to design, develop, produce, sell and service Medical Devices under controlled conditions,” said Dr. Dirk Colditz, Director Quality Management and Safety Officer Medical Devices of Definiens. “This is the ultimate precondition to receiving CE-approval to enable marketing of the company’s Medical Imaging software products and IVD-products, which are currently under development.”
