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Certifications

WE WORK HARD TO WIN YOUR TRUST

We place special emphasis on observing regulatory norms with a stringency paralleled by few in the industry. Thanks to our dedicated team of experts committed to ensuring we remain in line, our facilities are compliant with ISO 9001:2008, ISO 13485: 2003, NS-EN ISO 13485: 2012 and 21 CFR requirements of US FDA.

Adhering to the strictest standards in quality control, product design and development, prototyping, packaging and sterilisation, all our products are certified by CE, compliant with the European Medical Device Directive 93/42/EEC (as amended 2007/47/EC) and packaged as per EN 980 standards.

ISO 13485:2003 / NS-EN ISO 13485 : 2012 / ISO 9001:2008

EC Certificate - Implants & External Fixator

EC Certificate - Surgical Instruments

Free Sale Certificate

 

Export House Certificate

Drug License (Indian FDA)

GMP Certificate

US FDA 510k Certificate

 

ISO 14001:2004

WHO GMP Certificate

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