MANUFACTURING & AFTER-SALES SERVICES
More than 45 years of outstanding work for medical, in-vitro diagnostic, and life science clients globally
With more than 130,000 ft2 of floor space, we efficiently build and service equipment locally in Europe, USA, and China in compliance with ISO 13485 and FDA CFR 21. This allows our clients to obtain product supply and after-sales support from a location that provides logistics, regulatory, and geographical benefits in line with unique market needs. Utilizing Kaizen-based manufacturing methodologies across our entire organization creates continuous, positive improvements. By leveraging our global supply chain, we provide cost efficiencies to benefit our clients and those they serve.
OUR SERVICE OFFERING
Contract Manufacturing
We manufacture high quality, medium to complex IVD, medical, and life science devices. By applying Kaizen methodology, we continuously drive efficiencies and improvements in our operations.
Flexible Product Volumes
We can produce volumes ranging from dozens to thousands per year. We work together with you on a tailored solution to your business needs, allowing you to grow as a company.
Consistent Product Quality
Our ISO 13485 certified Quality Management System (QMS) is built upon well-defined processes, ensuring continuous improvement and the highest product quality.
100% Dedication to Medical Devices
Our global operations are fully dedicated to IVD, medical, and life science manufacturing and automation.
Reliable Design Transfer Process
We ensure a smooth technology transfer into manufacturing through an early collaboration of the design and manufacturing departments to safeguard the quality of the final product.
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Global Market Access
Our global presence allows us to manufacture in the market (Europe, USA, Asia) where your product is intended to be sold to strengthen your market introduction and early market share.
Reliable Lifecycle Management
We provide a comprehensive suite of lifetime support services to ensure product viability over the lifetime of the instrument, including upgrades and sustained engineering.
Worldwide Spare Part Management
We offer an FDA and ISO compliant setup of spare parts for OEMs including planning, manufacturing, handling, and shipping.
Local Service Depot and Field Service
We offer certified technical after-sale services in accordance with ISO 13485 to ensure product availability and success in the field.
OUR TECHNICAL CAPABILITIES

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

OUR FACILITIES

Germany

  • Contract development and manufacturing of medium-large IVD instruments
  • 86,000 ft2 and ISO 13485 certified

United States

  • Contract development and manufacturing of small-medium IVD instruments
  • 29,000 ft2 and ISO 13485 certified

CHINA

  • CNC-machining and component assembly operation
  • 18,000 ft2 and ISO 13485 certified
Examples of Our Work
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

Massarray® Nanodispenser RS1000

• Automated Bench Top Liquid Handler
• Client: Agena Bioscience, Inc
• 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

LISTEN TO OUR CUSTOMERS
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Christian Harwanegg
Macro Array Diagnostics
CEO

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.

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Eric Van Bladel
DRG International
COO

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.

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Jeffrey A. Klein
HK Surgical
CEO and President

One of the biggest advantages for us is BIT’s global presence because we have access to the expertise of their global talent. BIT’s access to its global supply chain has provided HK Surgical with a new, “best-in-the-market” product while meeting our demanding budget requirements. BIT’s client-centric approach and focus on our individual needs also provide us with flexibility and confidence that we will continue to grow internationally. The successful association between HK and BIT continues to support our position as a market leader.

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Dr. Claus Prümper
Siemens Healthineers
Franchise Lead Plasma Proteins

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.

WORKING ON A NEW MEDICAL DEVICE?
Mona Elkebir
Mona Elkebir
Vice President
Commercial Operations
irvine, USA