DSM Biomedical: ISO Certification Obtained
DSM Biomedical has obtained ISO 13485 certification in recognition of its quality management systems for its medical coating activities. This ISO certification broadens DSM’s access as a qualified supplier in the medical market. ISO certifications for DSM PTG and Dyneema Purity were already in place.
The company was awarded the certificate following a stringent evaluation of all processes with regards to the design and development, manufacturing and marketing & sales of polymer-based coatings and application technology for medical devices.
ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a Medical Device QMS ensuring steps have been taken to identify, manage and minimize the risks involved with the manufacturing and sale of medical devices.
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