Home / Business and Economy / SMT Secures Crucial EU MDR Certification
SMT Secures Crucial EU MDR Certification
24 Sep
Summary
- SMT's Supraflex Cruz stent family achieved EU MDR 2017/745 certification.
- The certification validates rigorous safety, performance, and clinical evidence.
- Supraflex Cruz has treated over 2.5 million patients in more than 75 countries.
Sahajanand Medical Technologies (SMT) announced it has achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745) for its Supraflex Cruz and its product family. This significant regulatory milestone confirms Supraflex Cruz meets the stringent requirements for safety, performance, and clinical evidence mandated by the EU MDR.
The certification followed a thorough conformity assessment, including a review of SMT's technical documentation, clinical evaluation, and quality management system. Supraflex Cruz, a sirolimus-eluting coronary stent system, has been instrumental in treating over 2.5 million patients across more than 75 countries. Its robust clinical evidence includes multiple randomized controlled trials and real-world registries.
This achievement is poised to support the continuity of supply and patient access to SMT's cardiovascular devices in Europe and globally. Company leadership emphasized that this certification reflects their technical rigor and quality discipline, reinforcing their commitment to physicians and patients. It marks a key step in SMT's ambition to become a global leader in cardiovascular care.
