Successful ISO 13485 re-certification


Following a successful audit for re-certification, our ISO 13485:2016 certificate has been renewed for another 3 year valid from July 6, 2024.

We are proud to announce that MELITEK has been successfully recertified according to ISO 13485:2016 by our notified body LRQA. 

Since 2018, our meliflex materials have been developed and manufactured under a QMS with ISO 13485:2016 certification which includes procedures on product risk assessment, product validation and post production surveillance which yield reliable quality for new products and lower risk to products in use. 

We trust our renewed ISO 13485:2016 certification will continue to strengthen our commitment to serve our customers with the highest quality of customized elastomer and polymer compounds.

For any additional information or questions, please do not hesitate to contact us.


The ISO 13485:2016 certificate valid from 2024-2027 is available for download here.