Evonik subsidiary certified as a supplier to medical device manufacturers

Evonik Industries subsidiary APT Europe GmbH has been successfully certified according to EN ISO 13485:2003. This international standard specifies requirements for the quality management systems of medical device manufacturers and their suppliers. Compared to ISO 9001, ISO 13485 places particular emphasis on ensuring consistent product quality and controlling and verifying all relevant processes, as well as documentation and traceability.

Manufacturers of medical devices must ensure that their suppliers comply with the requirements of EN ISO 13485. This certification simplifies the mandatory supplier qualification process for VESTAKEEP^® customers. Besides ensuring consistent product quality, Evonik is also making a significant contribution to reducing customer expenditures for medical device registration. The product portfolio of Evonik includes stock shapes made of VESTAKEEP^® PEEK medical grades for the manufacturing of biocompatible and biostable products.

Dr. Herbert Groothues, Regulatory Affairs VESTAKEEP^®: “We believe that our decision to become ISO 13485 certified is a proactive one that not only anticipates the demands of our customers but also demonstrates our commitment to providing quality services.”

VESTAKEEP^® PEEK polymers are used in medical technology because of their excellent biocompatibility and biostability. Implants made of VESTAKEEP^® PEEK are highly resistant to wear and have advantages to materials such as titanium in many areas. Applications include spinal and dental implants, orthopedic devices, and implants for oral and maxillofacial surgery.