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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, GermanyBIT 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