ISO Certificate

Our production plants have a certified quality management system according to the standard DIN EN ISO 9001. Products, processes, structures and machines are continually monitored and adapted to the progress in the rehab and industry branch.

 In addition, the system reliably complies with the requirements of the European Medical Device Regulation 2017/745 (MDR) including the required CE marking. In close cooperation with accredited testing laboratories, detailed extensive tests are carried out and required product certifications are obtained.

 Through regularly documented internal and external training of our employees, we are continually expanding and improving not only our products but also our overall performance and know-how. Furthermore, internal audits intensify the quality consciousness in the entire Rolko team.