“The IVD market is challenging for our clients,” explains Marius Balger, BIT CEO. “OEM’s must adhere to a growing number of evolving IVD regulatory requirements, while remaining innovative and competitive. Additionally, there is constant pressure to keep costs down and excel in the operation of their own businesses.”
After 40 years developing and manufacturing precision IVD instruments for global markets, BIT has achieved expertise, as well as a comprehensive understanding of global regulatory affairs, a vast knowledge base of new instrument innovations and software advances, and industrial design for manufacturability.
BIT focused its resources on developing a full range of white label, ready-to use IVD solutions where there was the most demand – on instruments performing standard applications within market segments such as Hematology, Clinical Chemistry and Homeostasis Diagnostics. BIT’s white label IVD instruments are totally customizable with regard to functionality, consumables and reagents. Even the industrial design of the instrument can be customized so the new white label instrument can emulate an OEM’s existing product line.
For the OEM, BIT’s white label solutions translate into a lower investment in resources, increased speed to market and enhanced cost efficiency. “And most important,” adds Balger, “OEM’s can focus on their own core competencies while BIT provides them with proven, innovative, fully-supported, highly-reliable, IVD instruments.”
BIT Group provides contract product development, manufacturing and after-sales services 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 BITSMARTSOLUTIONS™ platform technologies reduce development cost and time-to-market; lean manufacturing centers and global supply chain enable competitive product cost.