For those plastics processors and suppliers active in the medical device or medical packaging industries, ISO 13485 is shifting from a "nice to have" to one of the expectations of some customers. It just makes it much easier for them to vet you as a reliable supplier. Having the certification is further proof you're serious about serving the medical industry and are a capable partner/supplier.
|Semi-fnished PEEK parts using Vestakeep are made in a cleanroom.|
The EN ISO 13485:2003 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. Processors and suppliers such as APT Europe who earn the certification simplify the mandatory supplier qualification process.
APT Europe exclusively uses Evonik's Vestakeep material as a source material for the production of its semi-finished APT PEEK products. These are used in the medical space to create spinal and dental implants, orthopedic devices, and implants for oral and maxillofacial surgery. APT and Evonik have a similar cooperation in the United States.