BIT Group Opens IVD-Focused Contract Manufacturing Facility in China
BIT Group has officially opened EMD Shenzhen, Ltd. – a comprehensive IVD instrumentation & hematology reagent contract manufacturing operation in Shenzhen, China. EMD provides BIT’s IVD technologies developed in the USA and Europe, and manufactures products for clients while adhering to strict regulatory requirements.
December 9, 2016, Schwalbach, Germany – BIT Group celebrated the official opening of EMD Shenzhen, Ltd., – its second Chinese manufacturing operation in Shenzhen, China and a joint venture with EDAN Instruments, Inc., a Shenzhen-based leader in medical monitoring technology.
EMD is now BIT’s primary contract manufacturing hub for China and Asia and is already active with four new clients, including EDAN. The additional capacity and capabilities provided by EMD will enable BIT to provide comprehensive IVD manufacturing capabilities and third-party Contract Manufacturing Services (CMS). EMD focuses on contract manufacturing of IVD instrumentation, and hematology reagent manufacturing under contract for OEMs.
BIT’s clients benefit from the new 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. EMD provides BIT’s IVD technologies developed in the USA and Europe, and manufactures products for clients while adhering to the strict regulatory requirements of CFDA, FDA and ISO13485.
“The Chinese medical technology market is expected to grow at double digit rates in the coming years,” added Marius Balger, BIT CEO. “We are dedicated to improving quality of health around the world by delivering value- driven, innovative and high-quality diagnostic products and services. Our new 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.”
Messer Group shareholders, EDAN Senior management, clients and technology partners and government officials attended EMD’s inauguration.
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(TM) 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