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BIT Group Establishes IVD-Focused Contract Manufacturing Facility in China

BIT Group has established a comprehensive medical instrument outsourcing manufacturing operation in Shenzhen as a joint venture with EDAN Instruments, Inc., of Shenzhen, China. While BIT has operated an ISO9001 certified parts and modules manufacturing facility in China for several years, this new venture delivers increased capabilities, capacity and a focus in IVD instrument contract manufacturing.

October 29, 2015: Schwalbach, Germany – BIT Group has revealed the establishment of a second Chinese manufacturing operation in Shenzhen, China as a joint venture with EDAN Instruments, Inc., a Shenzhen-based leader in medical monitoring technology. The additional capacity and capabilities provided by the newest facility will enable BIT to provide comprehensive IVD manufacturing capabilities and third-party Contract Manufacturing Services (CMS).

“The Chinese medical technology market is expected to grow at double digit rates in the coming years,” explains Marius Balger, BIT CEO. “Our newest China facility will allow us to provide our clients with an outsourced CMS alternative to those which are not focused on the IVD business and lack experience with system development and system contract manufacturing.”

BIT specializes in contract product development, manufacturing and after-sales services for life science, medical and IVD instrumentation OEMs; EDAN is an established company in the medical monitoring business. By joining forces, both partners remain focused on core competencies, while providing a dedicated IVD contract manufacturing solution for OEM’s seeking entry to the China market or for local OEM’s requiring a transnational company to bridge local domestic needs.

BIT’s global clients will benefit from the new ISO1385-certified facility through competitive product pricing as well as Chinese domestic supply of product, lower transport and import costs, and an expedited regulatory approvals process within the Chinese market. BIT will offer CMS IVD solutions from this new facility to its clients globally.

BIT Group provides contract product development, manufacturing and after-sales services, as well as white-label instruments, for life science, medical and IVD instrumentation OEMs. Quality standards include GMP, FDA registered, ISO13485 & 9001, QSR, Class I, II, and III. BIT Group‘s global operations in USA, Germany, France, China & Japan deliver precision engineered, cost effective systems solutions. Pre-engineered BIT SMARTSOLUTIONS™ platform technologies reduce development cost and time-to-market; lean manufacturing centers and global supply chain enable competitive product cost.

Executive VP, Jari Palander
Phone: +1 (949) 238 1277