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Certification for medical products

Successfully certified: Röchling Oertl Kunststofftechnik, Brensbach, has introduced a quality management system for medical products in accordance with EN ISO 13485:2012

In injection moulding: Röchling Oertl manufactures highly complex components for medical technology

Röchling Oertl introducing quality management system as per EN ISO 13485:2012

Brensbach – Röchling Oertl Kunststofftechnik GmbH has successfully introduced a quality management system for medical products in accordance with EN ISO 13485:2012. With this certification by TÜV Rheinland, Röchling is further developing its position in medical technology.

Röchling Oertl manufactures highly complex and technically sophisticated parts in the injection moulding process that find application in medical technology and in the pharmaceutical field. They are implemented, by way of example, in dialysis or infusion therapy. For manufacturing these products, Röchling Oertl has now introduced a quality management system pursuant to EN ISO 13485:2012 and oriented the operational processes to fall in line with the requirements of this standard and have them thus certified.

Focus on patient safety

EN ISO 13485:2012 is the standard for quality management systems in medical technology. Products used in medical treatment must be safe. They must not have any negative influence on patients. This standard prescribes rules and regulations for operational processes to ensure that the products are suitable for implementation.

Joachim Lehmann, Managing Director of Röchling Oertl Kunststofftechnik GmbH, explains: “Certification confirms that in all internal operations and processes we observe the highest standards for the manufacture of our products. Moreover, the certification underscores our company’s high requirements.” EN ISO 13485:2012 supplements the quality management standard EN ISO 9001:2008, according to which the plastics processor has already been certified for several years.

Position in medical technology developed

With this successful certification, Röchling is consistently carrying on with the strategy of further developing the field of plastic products for medical technology. This group of companies leading plastics processing globally offers a comprehensive material and production range for medical technology with the injection moulding products of Röchling Oertl Kunststofftechnik and Röchling Advent Tool & Mold, Rochester (NY)/USA, as well as the Medical Grade semi-finished products of Röchling Sustaplast KG, Lahnstein and Röchling Engineering Plastics, Dallas (NC)/USA.