MELITEK is proud to announce that we have obtained ISO 13485:2016 certification for our Quality System covering sales, development and production of customized elastomer and polymer compounds for healthcare applications.
“MELITEK has since we commenced production of compounds in 1999, been devoted to serve the healthcare market, as such it became very natural path for us for us to strive for ISO 13485:2016 certification” says Kim Laursen, managing director of MELITEK. “This marks a milestone achievement in our companys continued growth to become a global leader of elastomer and polymer compounds special designed for healthcare applications”, he continues.
“Having our Quality Management System certified according to the new ISO 13485:2016 standard will strengthen our meliflex brand and provide further trust to our products”, supplements Jesper Laursen, business director at MELITEK. “We have for years included many principals of ISO 13485 into our ISO 9001 system, such as traceability and change management, but now following our new ISO 13485 certification our customers can trust that our quality system is in line with their own and meeting their expectations as strategic supplier of elastomer and polymer compounds to the healthcare industry.”
“Important additional activates under our new ISO 13485:2016 certification is that our product development now includes Risk Assessment and Validation activities that ensures further reliability to our products”, Jesper Laursen adds.
MELITEK will as a result of achieving ISO 13485:2016 certification, not renew our ISO 9001:2008 certification.