Press release - August 9th, 2009
cerbomed reaches another milestone with its ISO 13485-certification
Erlangen, August 9th, 2009. cerbomed gmbh, a start-up company in the area of neurostimulation, has obtained EN ISO 13485:2003+AC:2007 certification for its quality management system.
This certification confirms the successful introduction and application of a quality management system for medical device manufacturers, and covers all corporate divisions. Among other aspects, strategic processes, core processes of development and production, and supporting processes, were examined.
The EN ISO 13485:2003+AC:2007 certification is an internationally recognized quality management standard, which reflects the specific legal requirements placed on medical device manufacturers. "The extensive requirements of the norm have been implemented successfully in all corporate divisions. We have set up a quality management system that will make the process of registering our innovative product much easier for us”, explains Dr. Andreas Hartlep, Chief Technology Officer (CTO) of the company.
Introducing the quality management system highlights the vision of cerbomed gmbh to consistently develop its device for transcutaneous vagus nerve stimulation (t-VNS) in line with the highest quality standards, to steer the innovation successfully and directly to market maturity.
cerbomed is a young, medical device company focusing on the research, development and manufacturing of innovative technologies and products in the area of neurostimulation. Its major proprietary procedure, transcutaneous vagus nerve stimulation (t-VNS), will offer a new, alternative treatment for various neuropsychiatric disorders with clinical benefit and improved quality of life at a superior cost benefit ratio.
Since its foundation in December 2005, cerbomed has received many innovation and new enterprise prices (including university- and chamber of commerce new enterprise awards), and was among the federal winners of the German new enterprise prize in 2006.