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BIT Group provides contract product development, manufacturing and after-sale services, as well as white label instruments, to life science, medical and in-vitro diagnostics (IVD) instrumentation OEMs. BIT Group’s global operations in Germany, France, USA, China & Japan deliver precision engineered, cost effective system solutions. Pre-engineered BITSMARTSOLUTIONS platform technologies and white label instruments/systems reduce development cost and time-to-market; lean manufacturing centers and a global supply chain enable competitive product cost.
Quality and manufacturing standards include GMP, FDA Registered, ISO13485, QSR, Class I, II, and III.
BIT is an award-winning development company, specialized in the field of complex medical instrumentation. Focusing on specialized instruments/system integration, we can offer pre-developed & validated platform modules to aid in the creation of customized instruments. We can also offer customizable, fully-integrated, white label solutions to maximize speed to market, cost effectiveness, proven technology and validation surety. All of our systems are developed and manufactured within our global facilities in the USA, Europe and Asia.
At BIT, we understand that IVD, life science, and medical instrumentation & devices are complex, and creating them successfully requires skilled proficiency in numerous critical technologies. Excellence in product development demands innovation and creative ideation. Additionally, exceptional operational standards must be upheld throughout all phases – from concept through manufacturing and after-sale services. Cost control and design-for-manufacture skills are also essential. Finally, quality overall project management, as well as comprehensive system-testing services and validation support, are vital.
BIT has the experience and expertise to intelligently fuel innovative ideation. Through its global manufacturing and supply, BIT provides engineering talent and continuous involvement from product concept through Life-cycle Device History Record (DHR), including FDA-approved after-sale software tools for full traceability. KAIZEN-based work philosophy dictates strict standards of excellence – as demonstrated by the 170,000+ BIT instruments that have successfully analyzed, diagnosed and helped to heal people in over 35,000 labs around the world over the last 40 years.