Quality | Our Equipment : Our Certifications
EN ISO 13485:2003/AC:2007
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.
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.
FDA registration #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 regulations for establishment registration are provided in the PDF.
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 regulations for establishment registration are provided in the PDF.
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.
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.
I know that whenever I speak with your team, things get done and promises are kept. It’s rare to find that in any organization. It’s a testament to the values and ethics you are instilling at Onyx.
— G.C., Buyer/Planner, Leading Trauma Company
— G.C., Buyer/Planner, Leading Trauma Company