Regulatory Expertise and Commitment to Quality
Our global regulatory and registration expertise is at your service and our commitment to quality provides superior products.
Our global registration expertise improves speed to market in new geographies. We can assist you with the stringent regulatory demands in many countries around the world, including the Americas, Europe, Australia, Russia, India, and Asia Pacific.
All Nordson MEDICAL branded biomaterial delivery products are developed, manufactured and tested in accordance with applicable standards of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization, the Canadian Medical Device Conformity Assessment System, and the European Medical Device Directive 93/42/EEC. The Micromedics line of biomaterial delivery devices is certified by a recognized CMDCAS Registrar to ISO 13485 and particular requirements of ISO 9001 and CE marks products accordingly.
Quality systems compliance
US FDA 21 CFR Part 820
EU ISO 13485 certified