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 sterilization, 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.
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