Following the introduction of a quality management system for medical products in accordance with EN ISO 13485:2012 for medical devices, German group Röchling Sustaplast KG has been certified by TÜV Rheinland, the German technical inspection agent.
The company from the Rhine-Lahn region manufactures semi-finished plastic products that are used in devices for medical technology, among other applications. They are employed in surgery, dental technology, diagnostic radiology and treatment systems. For the manufacture of these products Röchling Sustaplast has introduced a quality management system compliant with EN ISO 13485:2012, tailored its operational processes to meet the requirements of the standard and obtained the appropriate certification from TÜV Rheinland.
For operational processes, the certification lays down standards that are intended to ensure that products are suitable for use in the industry. In implementing it, Röchling Sustaplast confirms the physiological safety of the semi-finished products and traceability back to the raw material batch.
“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”, said Eugen Schmidt, who heads up 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 group offers a range of materials for the medical sector through the product ranges of Röchling Sustaplast KG and Röchling Engineering Plastics KG, Dallas (NC) USA, and the injection moulding products of Röchling Oertl Kunststofftechnik, Brensbach, and Röchling Advent Tool & Mold, Rochester (NY) USA.
Ludger Bartels, COO of the Röchling Group, Mannheim said: “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.”