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Small Bone Innovations Inc. receives accreditation from Japan for its facilities
Small Bone Innovations Inc. announced its Morrisville, PA and Péronnas, France facilities have received manufacturers’ accreditation from the government of Japan. The accreditation will allow product registrations in Japan, according to a company release.
The award was described in the release as an important step in the company’s development of a strategic partnership with Olympus Terumo Biomaterials (OTB) Corporation, Tokyo, announced last year, to exclusively market a portfolio of small bone and joint implants and instrumentation in Japan — including the STAR Total Ankle Replacement System.
“The manufacturer’s accreditation in Japan is an imprimatur of quality and compliance required of any company seeking a credible presence in this market,” Anthony G. Viscogliosi, chairman and chief executive officer of Small Bone Innovations, stated in the release. “By joining with both Olympus and its OTB subsidiary we are gaining a foothold in one of the world’s most sophisticated orthopedics markets and advancing our growth potential in Asia Pacific.”
Japan’s Ministry of Health, Labor and Welfare issued the accreditation certification in the general manufacturing category for orthopedic products. The application included a full review of the company’s manufacturing standards and practices, as well as the ability of the partnership with OTB to deliver products throughout Japan in compliance with all relevant regulations.