Scalable from 1:10,000
Whether it’s small-batch production for startups or high-volume production for Tier 1 suppliers, we scale to meet your needs without compromising on quality.
Built for series
production
With the utmost precision and expert craftsmanship, we create exactly what you need.
Your requirements drive everything we do.
We offer maximum flexibility to meet your needs. Whether you require high or low volumes,
from large Tier 1 contracts to startup pilot runs. Thanks to our proven, global supplier network, we find the solutions you need: high-quality, cost-effective, and reliable. Since we handle both development and manufacturing under one roof, you benefit from a seamless transition from prototype to series production, without any friction or coordination issues. Fully traceable from the first assembly to series delivery.
We are fluent in regulatory matters
Having grown up working with Tier 1 partners, we are familiar with their quality management systems and know exactly what matters from a regulatory standpoint.
Made to measure. Not off the shelf.
Everything is customized. Each production line is built around your product.
Everything under one roof
Development and manufacturing share the same roof. Knowledge flows directly into production so that nothing lost or rerouted.
Need a reliable manufacturing partner?
Let’s build togehter.
“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.”
Your Questions
We ensure traceability and quality through comprehensive documentation: All components are fully recorded in our validated ERP system and clearly assigned to purchase orders, delivery notes, and accompanying documents. Critical components are additionally documented via lot numbers. This ensures seamless traceability.
All relevant inspection points are systematically recorded and digitally documented. This is supplemented by our dual-control principle in manufacturing, self-inspection by employees, random sampling, and 5S audits. Ensuring quality through clearly defined assembly and testing instructions.
Our quality management system is certified to DIN EN ISO 13485, the international benchmark for medical devices and in vitro diagnostics (IVDs).
For products intended for the U.S. market, we also manufacture in accordance with the requirements of the FDA Quality System Regulation (21 CFR Part 820). Our processes are designed to reliably meet the specifications of the U.S. Food and Drug Administration (FDA) and to support a smooth approval process.
Our global supplier network is built for situations just like these. If a supplier drops out, we switch to qualified alternatives, domestic or international, without interrupting your production.
Flexible framework agreements of up to 18 months mean we’re already well-positioned when demand spikes. Delivery stays reliable and on time, so you can stay focused on your core business.
