The company maintains ISO 13485:2016 certification, demonstrating compliance with international quality management standards for medical devices. Additionally, their WHO prequalification status for multiple products validates their commitment to meeting the highest international standards for safety, efficacy, and quality.

The manufacturing facility in Gurugram operates under Good Manufacturing Practice (GMP) guidelines and has successfully passed multiple international inspections, including rigorous WHO prequalification inspections that evaluated every aspect of their quality management system.

Certificates

• ISO: 9001 (2015)
• ISO: 13485 (2016)