BIT Group – Who We Are

What We Do

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.


Why BIT?
What Makes Us Different?

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.


Our Benefits Are Your Advantage

BIT GROUP QUICK-REFERENCE FACT SHEET

SERVICES

  • BIT is a comprehensive service provider offering product development, manufacturing and after-sale service for highly regulated FDA and ISO13485 market segment
  • BIT develops and manufactures instruments and devices for medical, in-vitro diagnostic and life science clients globally
  • BIT provides instrument after-sale service to maximize in-field reliability
  • BIT advocates for its clients and does not sell competing BIT-branded instruments

Product Development

  • BIT offers three development sites located in Germany, France and USA (California)
  • BIT has a Client Services office in Japan
  • BIT is FDA, QSR and CE IVD Directive compliant
  • BIT’s services include feasibility and concept creation, through product development and sustaining engineering services over the product life cycle
  • BIT offers BITSMARTSOLUTIONS platform technologies, as well as BITSMARTMODULES and White Label proven instrument solutions for flexibility and speed-to-market

Manufacturing

  • BIT manufactures in four sites located in Germany, USA / California and China / Kunshan & Shenzhen
  • BIT is ISO13485 certified, and FDA registered for IVD and medical devices

After-Sale Services

  • BIT offers after-sale services in Europe, North America and Asia
  • BIT’s after-sale service program is customized to client needs
Responsive Menu Clicked Image
Menu