Germany-based Röchling Sustaplast KG has been certified by TÜV Rheinland following the introduction of a quality management system for medical products in accordance with EN ISO 13485:2012.
“We meet the high standards expected of the manufacture of medical products. The focus is on patient safety. All our processes are geared to that,” states Eugen Schmidt, who heads the Medical Technology unit.
The certificate is valid for five years. TÜV-Rheinland verifies compliance with the specifications for the QM system in annual audits.
The certification is seen as Röchling’s strategy to extend its portfolio in the medical industry. It confirms the physiological safety of the semi-finished products and traceability right back to the raw materials batch. Röchling Sustaplast manufactures semi-finished plastic products that are used in devices for medical technology, among other applications.
Ludger Bartels, COO of the Röchling Group, Mannheim, is very satisfied with the introduction. “By establishing a quality management system in accordance with EN ISO 13485 we have taken a significant step forward on the way to strengthening our position as the leading supplier of plastic products for medical technoloogy. We will continue down this path consistently.”