16 Sep 2008
DSM Biomedical obtains ISO certification
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. DSM Biomedical’s patented ComfortCoat™ coating technologies can improve device performance in a wide range of applications and procedures. These coatings include innovative hydrophilic and anti-microbial coatings that can help improve patient comfort and care.
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. Certification to ISO 13485:2003 reinforces to customers through an independent third-party that DSM Biomedical operates its Medical Device QMS in accordance with the standard.
Steve Hartig, President DSM Biomedical “ISO 13485 is the standard when it comes to the reliability of the management system for the design and manufacture of medical devices. I am proud that within a relatively short period of time we have succeeded in implementing this internationally recognized system. This shows how committed we are to supplying high quality products that meet or exceed the expectations of our customers.”
Reader enquiries
DSM Biomedical
Postal address:
P.O. Box 18
6160 MD Geleen
The Netherlands
Visiting address:
Koestraat 1
6167 RA Geleen
Netherlands
Notes for editors
About DSM Biomedical
To meet the upcoming needs of the medical and biotech industries, DSM Biomedical builds on the expertise and strengths of DSM in polymers, coating technology, materials science and life sciences. DSM’s current biomedical portfolio includes ComfortCoat™ hydrophilic and antimicrobial coating technology for catheters, guidewires and other applications and Dyneema Purity®, a high performance polyethylene fiber technology, which has been developed inter alia for use in medical applications, such as orthopedic implants. Recently the company acquired PTG, a market leader in the field of biomedical polymers Furthermore, a research and development program specifically aimed at extending DSM’s material portfolio for the orthopedic industry has been started. In the drug delivery segment, DSM employs the Trancerta™ Drug Delivery approach which is based on DSM’s core strengths in polymers combined with its extensive in-house library of synthesis methods, formulation and processing techniques. For more information, visit www.dsmbiomedical.com.
DSM – the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM’s products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. DSM has annual sales of almost EUR 8.8 billion and employs some 23,000 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com
Forward-looking statements
This press release contains forward-looking statements. These statements are based on current expectations, estimates and projections of DSM and information currently available to the company. The statements involve certain risks and uncertainties that are difficult to predict and therefore DSM does not guarantee that its expectations will be realized. Furthermore, DSM has no obligation to update the statements contained in this press release.
Editorial enquiries
Inge Massen-Biemans
DSM Biomedical
Anouk Luykx
EMG