Munich, March 16th, 2011 – As a medical device company the Hepa Wash GmbH must meet the highest standards regarding the safety and reliability of its products and services. "The TÜV Süd examined and certified in an audit according to DIN EN ISO 13485:2009 that Hepa Wash fulfills all relevant quality criteria for the design and manufacture processes of medical devices and furthermore that a risk management process is effectively established", says Amelie Geiger, who is responsible for the quality management system of Hepa Wash GmbH.
The ISO 13485 contains all requirements of ISO 9001, the world's established standard for quality management systems, as well as specific requirements concerning the safety of medical devices. Additionally, Hepa Wash has established two more quality management systems: one for good laboratory practice (GLP) and another system for the implementation of the clinical trials (Good clinical practice – GCP).
"The successful certification is another fundamental step for Hepa Wash from an R&D start-up towards a fully established medical device company," says Dr. Bernhard Kreymann, CEO of Hepa Wash. "It’s also a satisfying conclusion of the remarkable progress the company has achieved last year: in the first half of 2010, Hepa Wash developed the clinical prototype and successfully passed the tests by the TÜV Süd concerning its compliance to standards and technical safety. In the second half, the clinical trials were started after approval of the Ethics Committee and the Federal Institute for Drugs and Medical Devices.
About Hepa Wash GmbH
Hepa Wash GmbH, which is located in the "Munich Technology Center" (MTZ), started in 2005 as a one- man company. Business purpose is the development and marketing of a new liver support device, to reduce the high mortality rate of patients with liver failure. Recent studies have shown once again that so far existing therapies have only very little positive impact on the survival of liver patients. However, the Hepa Wash device promises a significantly increased detoxification capacity. The data of the in vitro and preclinical studies confirm the excellent effect of the patented process. The clinical pilot study at the Klinikum rechts der Isar in Munich was started in October 2010. This study uses a TÜV-approved prototype of the device. Parallel to the pilot study, the company will complete the CE certification of the device. Hepa Wash has now ten permanent employees.
Description of Hepa Wash technology.
View the certificate.
Daniela Becker, Press Officer