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Quality     |     Our Equipment  :  Our Certifications  :  Our Validations
EN ISO 13485:2003/AC:2009
ISO standards make a positive difference. For our engineers and manufacturers, they help solve basic production and distribution problems. They also help in making the development, manufacturing and supply of products and services more efficient, safer and cleaner.
Japanese Manufacturing Certification
The Japanese Pharmaceutical Affairs Law (PAL) regulates medical devices distributed in Japan. It heralds both a change in market approval requirements and harmonizes with the international regulatory system of medical devices and IVD reagents. TÜV SÜD Japan Ltd. is a Registered Certification Body (RCB) - and can conduct medical device certification in compliance with the new legal regulations. TÜV SÜD America now offers clients PAL assessment services through TÜV SÜD Japan Ltd.
FDA Establishment Registration & Device Listing #1043653
Companies that produce and distribute medical devices for marketing or leasing (commercial distribution) in the U.S. must obtain FDA registration. Registration provides the FDA with the location of medical device manufacturing facilities and importers.
The energy you've put into providing us all requested information, accurately and quickly, is utmost appreciated. This is really contributing in building confidence and improving partnership at all levels between our companies.

— J.F., Quality Engineer, Top International Orthopedic Company