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Quality control and assurance

We are committed to providing you with products of the highest quality that comply with all applicable regulatory requirements, like the ISO 9001:2000 and 13485:2003 quality standards. Material Master Files of our products have been submitted to either the FDA or notified bodies in Europe. We provide authorization letters upon request to assist with your regulatory approval process.

Dedicated support
We can support you in identifying, developing or processing the best medical device or drug delivery system, based on your commercial needs. This support is built upon the excellence and commitment of our outstanding scientists and dedicated account management.

State-of-the-art facilities
Our products are developed and tested in our state-of-the-art facilities, including a dedicated application lab, a world-class analytical department, cGMP manufacturing facilities and biocompatibility assessment facilities.

Rapid access to know-how
Through DSM’s extensive scientific network, we are able to easily license in complementary technologies and knowledge whenever required.

Berkeley, CA facility

ISO 9001: 2000 Certificate (PDF: 268 Kb)
ISO 13485: 2003 Certificate (PDF: 320 Kb)

Geleen, Netherlands facility

ISO 13485: 2003 Certificate (PDF: 114 Kb)

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