Quality Assurance

Solco Biomedical practices thorough quality assurance management under its motto ¡®We pursue the healthy life of mankind with world best quality¡¯ as producer of medical equipment and instruments that treat human lives.
Its quality has been recognized home and abroad with ISO9001 and ISO13485 quality assurance system certifications, as well as the KS medical equipment certificate obtained in 1989 for the first time in Korea.
It has grown into a global business by exporting CE marked and FDA approved products throughout the world market.

Major Quality Certificates
License No. 121 on manufacture of medical instruments (Date first certified: 1978. 02)
KS mark (Date first certified: 1989.10)
Q mark (Date first certified: 1990.12)
KSA/ISO 9002 quality system (Date first certified: 1996. 04)
KGMP approved producer (Date first certified: 1999. 08)
KSA/ISO 9001 quality system (Date first certified: 1999.08)
US FDA 510K (Date first certified: 2005. 03)
ISO 13485 quality system (Date first certified: 2005.06)
CE mark (Date first certified: 2005. 06)

Solco Biomedical has a unified system that integrates all processes from product development to production, inspection, delivery and after sales service for all of its business lines, including implants, surgical instruments, medical equipment and healthcare products. All its officers and employees perform all their unit duties with their utmost devotion with such a thorough quality assurance system to ensure customer satisfaction.