Quality Assurance

Carmeda built quality into our technology 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 21 CFR Part 820 and ISO 13485. Carmeda is audited by the Dutch Notified Body, DEKRA. In addition, regular supplier audits are performed by our customers.

ISO 13485 2003 and EN ISO 13485 2012 (E)