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 compliance with 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, compliance with the European Medical Device Directive 93/42/EEC (as amended 2007/47/EC) and packaged as per EN 980 standards.

Free Sale Certificate

Drug License (Indian FDA)

bsi. CERTIFICATE MANAGEMENT SYSTEM-ISO 13485:2016

GMP Certificate

 

US FDA 510k Certificate

Export House Certificate

CE Certificate

MDSAP Certificate

 
High Risk Solutions