Quality Assurance

Carmeda has built quality into the technology by integrating quality assurance into all activities, from research and product development to manufacturing, training, and documentation.

Carmeda's quality management system meets the requirements of both FDA Quality System Regulation 21 CFR Part 820 and ISO 13485. Carmeda is audited by a Dutch notified body for medical devices, DEKRA. Regular supplier audits are also performed by customers.

Follow the link for Certificates