Quality assurance

We build quality into our products by integrating quality assurance into all our activities, from research and product development to manufacturing, training, and documentation.

Our quality management system meets the requirements of both the FDA’s Quality System Regulation: 1996, 21 CFR Part 820, and ISO 13485:2003.

Carmeda is certified to ISO 13485:2003 and is audited by the Dutch Notified Body, KEMA. In addition, supplier audits are performed by companies for whom contract coating is performed.