Quality

Our Quality Management

Christoph Miethke GmbH & Co. KG has been certified in accordance with ISO 9001, ISO 13485 and the Medical Device Directive 93/42/EEC since 1996. Our company philosophy says, that every step we take shall be based on quality – starting from the product development and research all the way to the customer service.

The company's internal Quality Management System assures the quality of the products. It concludes everything starting from the effective design project, reaching the extensive documentation and the highest possible care during the production all the way to the elaborate logistics supply chain offering the best supplier quality secured by effective reinspection of complete products. The people who stand behind Christoph Miethke GmbH & Co. KG are highly qualified and well trained to develop, manufacture and distribute some of the best products in the field of hydrocephalus treatment in the world. Our focus is to help the patients with hydrocephalus to get the best possible treatment they can get.

Certificates

Our company distributes all products in numerous different countries all over the world. We are the most familiar with the requirements of the Ministry of Health, Labor and Welfare of Japan as well as US Food and Drug Administration (FDA) and the requirements are integrated in our Quality Management System. The company is regularly inspected by several auditors of different countries of the world. We welcome customers and interested parties to visit us.

 

 

 

Produktion

Clean Room

All the products we produce in our cleanroom are manufactured under condition class 10.000. In order to ensure reliable and precise function of our products, numerous functionality tests are carried out already under production and once the devices are finished. Every single valve is carefully calibrated by hand and all data, especially concerning the operating performance, are determined and registered. The products are sterilized with steam in accordance to the standard DIN EN ISO 554.

 

Assembly

Our mechanics mount our handcraftet adjustment instruments, that do not need to be sterilized: e.g.: proGAV COMPASSES and proGAV VERIFICATION TOOLS

Production

Our degreed engineers and mechanics produce a large part of individual parts needed for the valve production in-house. Working with the latest CNC-machines allows a precise workflow tailor-made from the drawing up to the complete products.