2 hrs ago
Sahajanand Medical Technologies Receives EU MDR Certification for Supraflex Cruz
Sahajanand Medical Technologies makes devices used to help treat heart blood vessels.
It announced that its Supraflex Cruz stent received an important European certification.
The certification checks whether a medical device is safe, performs properly and has enough clinical evidence.
Experts reviewed the company’s technical documents, studies and quality systems.
The stent is designed to help open narrowed or blocked coronary vessels.
The company says it has been used to treat more than 2.5 million patients in over 75 countries.
Its evidence includes clinical trials and real-world patient registries.
SMT said the certification should help maintain access to the product in Europe and other markets.
Sahajanand Medical Technologies received EU MDR 2017/745 certification for Supraflex Cruz and its product family.
The certification followed assessments of technical documentation, clinical evaluation and the company’s quality management system.
Supraflex Cruz is a sirolimus-eluting coronary stent system for narrowed or blocked coronary vessels.
The stent has supported treatment for more than 2.5 million patients across over 75 countries.
SMT said the certification supports continuity of supply and patient access in Europe and globally.
- Who
- Sahajanand Medical Technologies Limited, including CEO Bhargav Kotadia and CTO Abhijeet Singhvi.
- What
- SMT received EU MDR 2017/745 certification for Supraflex Cruz and its product family.
- Where
- The announcement was issued from Mumbai, Maharashtra, India, while the certification supports access across Europe and globally.
- When
- September 24; the article does not specify the year of the announcement.
- Why
- The certification confirms assessment against European requirements for safety, performance and clinical evidence, while supporting continuity of supply and patient access.
Key facts
- Company
- Sahajanand Medical Technologies Limited
- Certified product
- Supraflex Cruz and its product family
- Regulation
- European Union Medical Device Regulation 2017/745
- Patient reach
- More than 2.5 million patients in over 75 countries
- Clinical evidence
- Four randomized controlled trials involving more than 5,000 patients
- Real-world evidence
- Seven registries involving more than 13,000 patients
- Existing certifications
- ISO 13485 quality management system and MDSAP certifications
Quotes
Abhijeet Singhvi
Chief technology officer of Sahajanand Medical Technologies
“EU MDR significantly raised expectations for clinical evidence, technical documentation and post-market surveillance.”
theprint.in
“This certification is more than a regulatory milestone, it is a statement of who we are as a company.”
theprint.in
Sources
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