Click on the PDF file below to download our ISO 13485:2016 certificate.ISO Certificate 13485_MELITEK_2021-2024.pdf
Announcement to customers
MELITEK is proud to announce that we have obtained ISO 13485:2016 certification for our Quality Management System.
MELITEK has since we commenced production of compounds in 1999, been fully devoted to serve the healthcare market and as part of our strong desire to be our customers’ preferred supplier for elastomer and polymer compounds, we have taken the strategic decision to adopt our Quality Management System to ISO 13485:2016.
We expect this will strengthen our meliflex brand, provide further trust to our products and bring value to our customers.
Our ISO13485:2016 certification, will not impose any change to our products, since these are covered by the meliflex concept which for years have incorporated key elements of ISO13485, including full traceability, change control management, extensive line clearance, controlled operation procedures, and good documentation practices. However, with the new certification we trust that the meliflex concept will be even better recognized by our customers, since the materials are now developed and manufactured under a QMS with ISO 13485:2016 certification.
Our new certification includes the scope for product development that includes procedures on product risk assessment, product validation and post production surveillance, which will yield more reliable quality for new products and lower risk to products in use.
Please be informed that MELITEK will, as a result of achieving ISO 13485:2016 certification, not renew our current ISO 9001:2008 certification when it expires.
We trust our new ISO 13485:2016 certification will further enforce our commitment to serve you with the highest quality of customized elastomer and polymer compounds. For any additional information or questions, please do not hesitate to contact us.
Kim Laursen Jesper Laursen
Managing director Business director