Global Production and QM System • Global ERP System • Global Supply Chain • Value Stream/ Kaizen Methodology • Kanban Material Flow System • Cell-based Assembly and Testing • Packaging and Distribution • Incoming Parts Inspection • First In First Out Warehousing • Wet Lab Testing • Quality Assurance Lab Testing • 3D-Printing • CNC Machining • FDA and CE Documentation • ISO 13485 Certified Facilities • FDA 21 CFR Part 820 Compliant • CE IVD Directive • IVD Regulation
Germany
- Contract development and manufacturing of medium-large IVD instruments
- 86,000 ft2 and ISO 13485 certified
CHINA
- CNC-machining and component assembly operation
- 18,000 ft2 and ISO 13485 certified
Atellica® NEPH 630
• Automated Bench Top Nephelometric Analyzer
• Client: Siemens Healthineers
• Co-Development, Manufacturing, After Sales Service by BIT
Respons®910
• Automated Bench Top Clinical Chemistry Analyzer
• Client: DiaSys Diagnostic Systems
• Co-Development, Manufacturing, After Sales Service by BIT
Hematek® 3000 System
• Compact Semi-Automated Benchtop Slide Stainer
• Client: Siemens Healthineers
• Co-Development, Manufacturing, After-Sales Services by BIT
Alegria®
• Bench Top Random-Access ELISA Analyzer
• Client: ORGENTEC Diagnostika
• Co-Development, Manufacturing, After-Sales Services by BIT
We have been working with BIT since early 2016 and have just started our third IVD instrument development project. Having the guidance of an experienced team with very little turnover, the uncertainties of automation development become manageable for an application-driven startup company. BIT has also maintained our aggressive time-to-market schedules and design-to-cost constraints. This is of equal importance of BIT having all functions from instrument design to field service under the same roof and management.
Our strategic partnership with BIT began when our company decided to expand from selling strictly consumables to include a fully automated diagnostic instrument. Not only did BIT take point in the design and development of our instrument, but the team successfully transitioned it into a full production project and later made incremental hard and software improvements based on feedback from the market. The senior management team at BIT was and continues to be very flexible, supportive, and pragmatic in their decision-making process as we collaborate with them. Although they are part of a multibillion-dollar conglomerate, they have the flexible thinking of a medium-sized company. Their senior management team, therefore, remains actively involved in key decisions which is critical for us.
BIT and Siemens Healthineers are looking back on a more than 40 Years successful partnership. I experience this cooperation as a true team approach with a forward-leaning attitude and absolute commitment to ‘deliver’ – be it physical or on project goals. Thanks to our joined focus on quality, we have been able to serve our customers extremely well and through this could establish a solid and respected market position in many diagnostic segments.
Sales
Schwalbach, Germany
Business Development
Montpellier, France