ALL OUR DESIGN AND MANUFACTURING SERVICES comply with FDA QSR 21 CFR - Part 820 and are ISO 13485:2003 Certified for design and manufacturing of medical devices. To ensure that we maintain our quality standards, we are audited each year by our notified body, TÜV SÜD. We regularly perform Internal and External auditing, and frequently support customer audits. Our current ISO 13485:2003 Certificate of Registration is for the "Design, Development and Analysis of Medical Devices along with Component Manufacturing and Assembly of Medical Devices."
Download our ISO 13485 certificate: ISO 13485:2003