LITRONIK Batterietechnologie GmbH successfully achieves EN ISO 13485:2016 certification
LITRONIK, an MST company and a specialist in the development and manufacture of compact, ultra reliable batteries for active implants, has successfully completed EN ISO 13485:2016 certification, the international standard for quality management systems for medical devices.
LITRONIK has been ISO 9001:2008 certified since 1999, maintaining a comprehensive quality assurance program. The ISO 13485 certification validates LITRONIK’s quality system and confirms LITRONIK’s commitment to medical technology and its stringent demands in fulfilling customer and regulatory requirements.
LITRONIK was audited by TÜV SÜD Product Service GmbH, an internationally recognized certification body that has been assessed and accredited by numerous accreditation bodies.
About LITRONIK Batterietechnologie GmbH:
For more than 20 years, the company has developed and manufactured sophisticated energy sources in a variety of performance ranges. The primary batteries for implantable application feature very high volumetric energy and power densities, low self-discharge rates and high operating safety. LITRONIK supplies high-performance batteries to manufacturers of pacemakers and defibrillators.
LITRONIK is headquartered in Pirna, Germany and a company of the Micro Systems Technologies group.
About the Micro Systems Technologies group:
The Micro Systems Technologies Group comprises four technology companies providing innovative components and miniaturized, integrated electronic module solutions for medical devices and other high-reliability, high-performance markets.
Active around the globe, the MST companies DYCONEX AG (Switzerland), LITRONIK Batterietechnologie GmbH (Germany), Micro Systems Engineering GmbH (Germany) and Micro Systems Engineering, Inc. (USA), offer their customers integrated solutions ranging from initial design through to series production.
LITRONIK Batterietechnologie GmbH
Birkwitzer Strasse 79
Phone +49 3501 5305 0
Fax +49 3501 5305 6999