Adhesive Plasters and Heart Catheters
WQS Management Consultants certify Medical Products
Every Medical Product, from adhesive plasters to pharmaceuticals and prostheses to complex heart catheter measuring stations, requires approval with extensive documentation requirements. WQS Management Consultants is one of the few companies in Germany that support manufacturers in the approval process in order to ultimately be able to market their products with the coveted CE mark. Werner Wiatrek, a graduate engineer in chemical process engineering, founded the company in Bockum-Hövel in 1993. Since 2011, he has also been producing sterile anti-fogging solutions for endoscopes.
It was only in 1996 that the approval of medical devices was regulated at the European level, and after 2012 the documentation requirements were once again significantly tightened. As a result, demand for WQS’s services increased rapidly. “I quickly shut down my Russian and English websites,” says the company founder. ”For us, the top priority is to meet the very highest quality standards – only in this way can we achieve sustainable growth.”
A team of 13 highly qualified employees from various scientific disciplines pore over technical literature, examine prototypes, test and document the products in Bockum-Hövel. Its customers range from small to very large in the pharmaceutical and medical industry. Wiatrek works closely with the Hamm-Lippstadt University of Applied Sciences and also participates in clinical studies. “Specialized university graduates are only now entering the market,” he observes. Wiatrek, on the other hand, celebrated its 20th anniversary two years ago.
