Our business practices and processes are designed to achieve quality results that exceed the expectations of patients, customers, surgeons. We are dedicated to the delivery of quality healthcare products around the world.

From the start of development of a new device through manufacturing to the final QC check before delivery, Quality is built in to all our products, as is our commitment and dedication to our customers throughout the world.

Both plants are certified to the highest international quality standard, ISO 13485. Regulatory compliance is an essential requirement. Our products comply with the various regulations established across the world, specifically those required by the Food and Drugs Administration and the European Union.

Documents availables on demand

• Certificates of SOPRO and SOPRO-COMEG’s quality management system according to the international standard ISO 13485: 2003


• Certificates of SOPRO and SOPRO-COMEG’s quality management system according to the international standard ISO 13485: 2003 (issued according to CMDCAS program requirements)


• EC Attestations issued for all our class IIa and IIb devices

All our medical devices have the EC mark and comply with the requirements of the European Directive 93/42/EEC.