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DSM in Medical

Quality is a key value

Quality is critical in our business and we’re committed to providing products that comply with all applicable regulatory requirements.

In 2017, we received the Medical Device Single Auditing Program (MDSAP) Certificate. In 2018, we transitioned three of our sites to the new ISO13485:2016 standards.

Rene Hogenboom, Sr. Director, Global Quality, explains Quality Management at DSM Biomedical  

Quality people and processes equate quality products

Years of experience and a high level of expertise have given DSM a comprehensive understanding of how the body reacts to foreign materials placed inside it. This enables us to design materials that are compatible with the body’s physiology.

For DSM, the definition of quality includes a thorough understanding of the rigorous requirements for medical devices and the assurance that our materials will help manufacturers develop devices that sustain, restore or repair. Our commitment is demonstrated through our high-quality materials and their ongoing use in products that benefit millions of people worldwide. We comply with all applicable regulatory requirements, like the ISO 13485:2016 quality standards. Material Master Files for many of our products have been submitted to the FDA and appropriate agencies in Europe.

Quality processes

Quality is built into our processes and confirmed by in-depth quality checks throughout our processes (as defined in our ISO-compliant integrated quality management system). Our state-of-the-art facilities include dedicated application labs, world-class analytical departments, and work with cGMP compliant manufacturing facilities and biocompatibility assessment facilities.

Quality people

Among our 22,000 employees are some of the world’s brightest scientists and biomedical engineers. Working in our sophisticated research facilities, these dedicated individuals have repeatedly found innovative solutions to the tough challenges facing medical device manufacturers and biopharmaceutical companies.

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