Komturstr. 18A  D-12099 Berlin Germany 

 

 

             

            

           

           

            

 

 

 

 

 

                  

 

 

                    

 

Our philosophy

MedInnovation GmbH – an obligation to

quality management

As a producer of in vitro diagnostics and medical devices for research and development, as well as being a partner for various hospitals, research-institutes and the pharmaceutical industry, we have a high level on demand of quality.

This high level of quality of our products and its utmost performance in our customers contentment is the declared aim of MedInnovation GmbH.

Continuously we are doing our best to increase the already high level of quality standard and customers’ satisfaction. In order to prove and realize this claim in our daily work, MedInnovation has committed herself strongly for a quality management and has successfully installed a respective quality management (QM) system in the company.

The date of March 16th, 2005, therefore, was another important date in the young history of our enterprise.

In the frame of an extensive audit, the TUV Rheinland Product Safety GmbH in the Cologne as an authorized notified body, has audited our company by analyzing the management, the organizational structure, the risk-management and the production processes and has given an unrestricted certification after approval of all presented documents and files.

With receipt of the certificate in accordance with EN ISO 13485:2003 the management and staff members of MedInnovation GmbH do not only express their engagement and obligation for a high level of quality and service, but furthermore have set a mile-stone for fulfilling the requirements of the IVD-guideline 98/79 EG, enclosure III, released by the European Parliament.

We are proud on these results and thank our employees and all respective participants for their exceptional engagement.

 

MedInnovation GmbH

The Management

 

declaration of conformity for In-vitro-diagnostics