Quality and Environmental Standards

Regulatory requirements and customer needs have driven Gayatri Medikraft Inc to obtain certification of our Quality and Environmental Management Systems. We comply with the highest standards and regulations in order to legally design, manufacture, distribute and sell medical devices throughout the world and to give our customers confidence that our products are of the highest quality.

ISO 9001:2008 – Quality Management Systems

Certification to the internationally recognized Quality Management System ISO 9001:2008 enables Gayatri Medikraft Inc. to demonstrate commitment to quality and customer satisfaction. The framework of continuous improvement of company processes reinforces our corporate culture.

ISO 13485:2012 – Medical Device Quality Management Systems: The basis of all regulatory requirements for placing medical devices worldwide markets is ISO.

13485:2012. Regular audits by Satra help to monitor and improve our management systems.

93/42/EEC – the Medical Devices Directive

Access into European markets is made possible by certification to the Medical Devices Directive. This enables CE marking.

of all Gayatri Medikraft Inc. products. The combination of certification to this Directive and ISO 13485:2012 is accepted for market entry in many countries.