ELMED was established in 1991 in Ostim, Ankara as the first hi-tech ESWL systems manufacturer in Turkey. One of today’s market leaders, ELMED undertakes production, domestic and export sales in the field of urology, and offers cutting edge hi-tech devices to the medical world for breaking up stones. Committed to developing new technologies and hi-tech products in the field of urology, ELMED has been following emerging technologies and market needs for almost 30 years in order to design, develop and market innovative, effective and advanced new products. With Tubitak Teydeb-1511 R&D support, ELMED has invented and perfected the AVICENNA Roboflex, Turkey’s and the world’s first Flexible Ureteroscope Robot for robotic applications.
Having completed more than 900 setups in more than 60 countries across 6 continents, ELMED holds CE documentation for its entire product range for meeting high safety and performance criteria required by the European Medical Device Directive.
ELMED , takes the required technological steps in all stages of the system starting with the purchase.
For a continuously improved medical performance, we follow modern business management principles to ensure the safety and reliability of our products and to meet the expectations of healthcare workers, patients and the society. This includes the implementation of a quality management system based on EN ISO 13485:2016 and EN ISO 9001:2015 standards, thus meeting existing legal requirements as well as those set by the authorities. In other words, our quality policy ensures compatibility between our products and the legal provisions in our target markets. The Medical Device Directives (93/42/EEC and 2007/47/EC) in the EU market drive our understanding of quality.
Our system covers all quality-related processes throughout the company.
Our quality policy is driven by the basic principles outlined below: