Our Services

One partner. Three competencies.
Everything under one roof and perfectly aligned.

Consultation meets
Implementation

Many companies only develop and manufacture. We think alongside you to find the best solution together.

As a medical device CDMO with a truly comprehensive portfolio, we cover your entire value chain in medical technology and laboratory automation: Research & Development, Manufacturing, and Product Maintenance. All three areas are organized under one roof, are regulatory compliant (ISO 13485, FDA 21 CFR, IVDR/CE), and are designed for seamless handovers. What is created in development can be manufactured at the same location and is maintained throughout its entire lifecycle by the same teams who know it inside and out. This saves you time, reduces interfaces, and minimizes risk. And it means you have a single point of contact.

Our three service areas that are seamlessly integrated:

R&D: The Think Tank

We turn your idea into a market-ready product. BIT supports you right from the initial concept and helps you navigate through the regulatory requirements, technical complexities, and time constraints. So that you can scale effectively without running into regulatory roadblocks.

Manufacturing: The Precision Floor

We produce modules, instruments, and processes with utmost precision and industry expertise.

Because development and manufacturing take place under one roof, we achieve a seamless transition from prototype to series production without any friction or coordination issues.

Maintenance: The Support System

Even after the product launch, we continue to support you: we inspect, maintain, and repair your equipment, and we think ahead with you. Because medical, diagnostic, and laboratory equipment has a long lifespan, we go the distance with you.

We ensure that your products meet all necessary standards.

When it comes to medical, diagnostic, and laboratory devices, quality isn’t an option—it’s a prerequisite. That’s why regulatory compliance isn’t an afterthought at BIT; it’s built in from the very beginning. Our in-house regulatory team supports every project from the initial concept phase through to market launch.

ISO 13485-certified at all locations
FDA-registered and GMP-compliant
CE and IVDR-compliant development and manufacturing
In-house regulatory experts on every project

“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.”

– Christian Harwanegg, CEO Macro Array Diagnostics

Your Questions

Yes, that is genuinely one of our greatest strengths. Since development and manufacturing take place under one roof at BIT, both teams work closely together from the very beginning. This saves time, avoids coordination issues, and ensures a smooth transition from prototype to series production.

Yes, of course. Our experts assess your device, and work with you to identify potential cost savings manufacturing optimization. This way, you can avoid unpleasant surprises later in the field.

Absolutely. Through component updates, expanded functionality, new electronics, and modern software architecture, we extend the lifecycle of your product and always account for all necessary regulatory measures.

Any questions? We’re here to help.

Stefan Koerth
Director Sales

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