Certified quality requirement
Our various certifications prove our drive for excellence to meet your needs. Our highly-qualified personnel combined with our quality service guarantee both maximum reliability and security. All our listed products are subject to a clearly-defined manufacturing protocol so as to guarantee both the product quality and security. Our tracking system allows us to trace back to any production or material defects and to immediately implement the appropriate corrective measures.
CE 93/42/CEE: BS-MTI manufactured products are marked CE pursuant to the European Directive 93/42/CEE. These technical files are updated and we closely follow all regulatory changes.
ISO 13485:2016: The company BS-MTI has been ISO 13485 certified since its creation. The management encourages an on-going drive for improving the quality system to be better prepared for changing requirements in the field of medical devices.