Certifications

Home > Certifications

Compliant with Global Standards

Our manufacturing and quality processes are certified to ISO 9001:2015 for Quality Management Systems and EN ISO 13485:2018 for Quality Management Systems specific to Medical Devices. We maintain a safe working environment through OHSAS 18001:2007 Occupational Health & Safety Management standards. Our medical electrical equipment complies with IEC 60601-1 safety standards, and our products are CE Certified, fully conforming to the Medical Council Directive 93/42/EEC.

ISO 9001:2015

ISO 13485:2016

ISO 45001:2018

IEC 60601-1-2:2014

CE Certified

US FDA Approved

CDSCO

TOP