Complete solutions from a single provider.
As a specialized development service provider, we offer customized solutions for the development of devices in the field of life science laboratories and in vitro diagnostics (IVD). We accompany you from conception to production and develop all the necessary components—from electronics and software to mechanics.
Our expertise encompasses the development and integration of control and operating units for measurement technology, sensor technology, and actuator technology. We offer solutions for both compact tabletop devices and large-format devices. Upon request, we develop according to the highest standards, such as ISO 13485, IVDR, 21 CFR 820, and GAMP® 5, to ensure that your products are safe and compliant with standards.
Benefit from our in-depth expertise in software, electronics, and mechanics—supported by our holistic system engineering approach, which ensures the efficient and error-free development of your IVD systems. Trust in our experience to deliver innovative, reliable, and high-performance solutions for your requirements.
Development services.
We offer complete development of equipment solutions, devices, and software for in vitro diagnostics (IVD)—from the initial idea to a market-ready, approvable product. We take care of all the necessary documentation and ensure that your product meets all regulatory requirements for approval. Trust our expertise to bring your IVD products to market efficiently, in compliance with standards, and with the highest quality.
Feasibility analysis & design
We support you right from the start with in-depth feasibility analyses to accurately evaluate your ideas and identify the best development opportunities. Our expertise in creating technical product concepts and visualizing system solutions or components enables us to make your vision clear and tangible—for targeted and efficient implementation.
Advice on technology selection and approval
Our experts provide comprehensive advice on selecting the optimal technologies and guide you through the entire approval process. We ensure that your product is not only state-of-the-art in terms of technology, but also meets the requirements for placing it on the market. This allows you to bring your innovation to market safely and quickly.
Development
- Holistic consideration of hardware, software, and mechanical requirements through system engineering
- Creation of functional, non-functional, and qualitative product requirements based on use cases
- Software development for embedded Linux systems, real-time operating systems (RTOS), or bare-metal solutions, as well as medical apps
- Refactoring of existing software to improve performance or further develop existing systems
- Development of software with software safety class up to C according to IEC 62304
- Electronic recording of device-specific process sequences, such as logging sensor data or user-dependent GUI inputs, in accordance with 21 CFR 11
- Development of interfaces for connecting devices to hospital information systems (HIS) (e.g., HL7, GDT)
- Development of visualizations and human-machine interfaces (HMI) with the utmost attention to usability and user-friendliness
- Hardware development in accordance with the requirements of EN 60601-1 for medical devices • Consistent and transparent implementation of functional safety (first-failure safety)
- Realization of housings with hygienic design and protection classes up to IP69K for high requirements in terms of cleaning and robustness
- Development of laboratory equipment and production facilities in accordance with GAMP® 5 for qualified automation solutions
- Process-compliant implementation of tailor-made solutions for cybersecurity, with particular emphasis on the combination of safety and security
- Competent management of IT risks in accordance with ISO 31000 • Efficient and automated verification and validation by our specialized department
- Provision of documentation for approval in European and American target markets
- EMC & ESD testing during development
- Creation of secure source code and performance of security-related tests in accordance with EN 50128 and IEC 62443
With our expertise, we support you in all phases of development to ensure that your medical device meets the highest standards and complies with all regulatory requirements.
Series transfer & follow-up support
- Support with the approval of medical devices (CE, UL, and FDA) and support with recertification, for example, in the event of component changes
- Our Product Security Incident Response Team (PSIRT) provides support as part of product maintenance or, on request, coordinates all activities to ensure cybersecurity throughout the entire product life cycle
- Support within the scope of product life cycle management (PLC), for example in the event of component discontinuations or product changes
- L2 and L3 support
- Support for the PSIRT team in product maintenance
Guidelines & standards.
We are certified according to EN ISO 13485 and work in accordance with the following guidelines and standards, among others:
- Verordnung für In-vitro-Diagnostika IVDR (EU) 2017/746
- Medizinprodukteverordnung MDR (EU) 2017/745
- Maschinenverordnung (EU) 2023/1230
- Maschinenrichtlinie 2006/42/EG
- FDA 21 CFR Parts 11 und 820
- IEC 62366 Medical devices - Application of usability engineering to medical devices
- IEC 62304 Medical device software - Software life cycle processes
- ISO 14971 Medical devices - Application of risk management to medical devices
- EN ISO 13849 Safety of machinery - Safety-related parts of control systems
- IEC 61010 Safety requirements for electrical equipment for measurement, control, and laboratory use
- EN IEC 62443-1 Security for industrial automation and control systems
- IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product lifecycle
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-2 Particular requirements for the basic safety and essential performance of medical electrical equipment
- ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
Developed products.
Our technologies are used wherever the highest demands on functionality, safety, and reliability are placed in the field of lab automation. Here are a few examples of customized solutions we have developed for the lab automation sector. Put your trust in our innovative solutions, which will make your processes more efficient, safer, and more future-proof.
