In vitro diagnostics

Customised technology
for medical diagnosis

Precise diagnoses require reliable data. Our in-vitro diagnostic devices reliably analyse samples such as blood or tissue, for example by combining PCR and capillary electrophoresis for DNA quantification.

A reliable data basis is essential for a valid medical diagnosis. The collection and evaluation of this data is greatly facilitated by laboratory equipment for in vitro diagnostics. We develop specialised medical technology for our customers and their specific applications.

These in vitro diagnostic devices analyse samples of all kinds from or from the body and are characterised by their complex mode of operation. For example, for multiplex DNA quantification, DNA amplification (PCR) is combined with capillary electrophoresis (CE).

We take on the complete development of customised diagnostic systems: from design and usability engineering to validation, approval and optional small series production.

We take on the complete development of sophisticated diagnostic systems for our customers, including the design and integration of all subsystems. With our expertise in product design and ergonomics, we ensure optimal usability, because we follow the approach of usability engineering: this means that we already consider user-friendly applicability in practical operation during product development. Our comprehensive service also includes product validation and approval. If desired, we can also organise the production of the product in small series.

Take the same Contact and we will work with you to develop customised technology for in vitro diagnostics.

With our full-service offer, from development to validation and approval to small series production, you as a customer save time and resources. You receive certified, ready-to-use diagnostic systems without any development risks of your own.
In-vitro-Diagnostik – imk Health Intelligence
🔬 In vitro diagnostics

Accurate diagnoses require reliable data.

We develop bespoke in vitro diagnostic systems tailored to your specific application. From the initial enquiry through to certified small-scale production, all from a single source.

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Our services

End-to-end development for your diagnostic systems

A reliable data set is essential for a valid medical diagnosis. We handle the entire development of sophisticated in vitro diagnostic devices in accordance with your requirements, including design, validation and small-batch production. We also assist you with the regulatory approval process.

Montage Diagnostikgerät imk Health
System design

Design and Usability Engineering

We develop diagnostic devices using a usability engineering approach. Usability in practical use is integrated into the product development process from the outset, rather than being added as an afterthought.

Montage Diagnosegeraet
Integration

Complex system integration

Our diagnostic systems combine several technologies in a single device. For example, we combine DNA amplification via PCR with capillary electrophoresis to enable precise multiplex DNA quantification.

Auswertung Diagnostik Ergebnis
Manufacturing

Small-batch production

We guide you through the entire approval process and, if required, can also handle the subsequent small-batch production. You will receive a certified, ready-to-use product.

Our process

From requirement to a solution that meets regulatory requirements

Structured, transparent and with no development risk on your part.

Requirements analysis

We work with you to identify technical, regulatory and application-specific requirements. Comprehensively and accurately.

Design and integration

System design, subsystem integration and usability engineering are incorporated into the development process right from the start.

Validation and approval

We handle product validation and assist you with regulatory approval.

Small-batch production

On request, we can handle production in certified small batches. You will receive a product that is ready for use.

Deep Well Plate PCR Kapillarelektrophorese
Example: MultiDiag
Technological depth

Complex analysis. Easy to use.

Modern in vitro diagnostics require the integration of multiple technologies within a single device. We integrate sophisticated techniques such as PCR, capillary electrophoresis and fluorescence detection into compact, validated systems with an intuitive user interface.

  • Multiplex DNA quantification using PCR and capillary electrophoresis
  • Analysis of blood, tissue and other types of samples
  • Usability engineering for safe use in everyday clinical and laboratory practice
  • Complete system integration of all subsystems from a single source
Fertig montiertes Diagnostikgerät imk Health
Full service: Development through to small-scale production
The benefits for you

No development risk. Certified. Ready for use.

With our full-service offering, you as a customer save time and resources. You do not need to build up your own development expertise for complex IVD systems. We deliver the finished, market-ready product.

  • No development risks for the customer
  • A single point of contact from concept to series production
  • Regulatory support
  • Small-batch production available on request immediately afterwards
Discuss your requirements now →
Katharina Herrmann
Your contact person Katharina Herrmann Business Development Manager

Bespoke technology for your diagnostic needs.

Tell us about your specific application. In a free initial consultation, we will show you how we can develop your diagnostic system, from the initial requirements right through to regulatory approval.

Arrange a free initial consultation → 100 % free of charge and with no obligation