Axiom Worldwide Receives Japanese Certification as a Medical Device Manufacturer

Business Wire, Nov 26, 2007

TAMPA, Fla. -- Axiom Worldwide today announced that on October 31, 2007 the company received Japanese certification as a medical device manufacturer. Meeting Quality Management System requirements and other regulations for the manufacture and sale of Medical Devices around the world can be complex and confusing. Japan's Pharmaceutical Affairs Law (PAL) harmonizes requirements and reduces some of the conflicting demands by incorporating the guidance documents of the Global Harmonization Task Force (GHTF). This includes quality management systems (QMS) requirements based on ISO 13485:2003.

To sell medical devices in Japan manufacturers must do more than register to ISO 13485:2003. However, the requirements stipulated from the Japanese Ministry of Health, Labor and Welfare (MHLW) come from Ministerial Ordinance 169, but are still based on ISO 13485:2003. The Japanese government has very stringent policies and processes in place to insure the quality, safety and efficacy of medical devices sold within the Japanese market. The certification that was received on October 31st demonstrates Axiom Worldwide's compliance under PAL as a medical device manufacturer. Being awarded this certification is further testament to the high quality standards that Axiom Worldwide has committed itself to.

About Axiom Worldwide

Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-Surgical Spinal Decompression System[TM], DRX9000C[TM], and DRX9500[TM] in medical markets around the globe. Axiom also manufactures an all-digital electroceutical device, the EPS8000[TM], for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery. For additional information on Axiom Worldwide, please visit www.AxiomWorldwide.com or contact Axiom Worldwide, 9423 Corporate Lake Drive, Tampa, FL 33634, telephone: 1-813-249-6444.