R&D/Consulting

Dmed Dialysis Business unit R&D

R&D/Consulting

Renal Engineering

From Germany
to the World

D.med Consulting GmbH is a leading specialist in extracorporeal technologies and other related medical fields.

From the initial idea to the finished prototype, we develop new suitable solutions, re-engineer existing products, and prepare your market launch.

We do not work in a preset structure but develop tailored solutions in cooperation with our clients. We’re looking forward to talking to you!

R&D

Product Development

Based on your expectations and our expertise, we develop your product from the initial idea to the final registration.

If you have a development department, we are also very familiar to consult you in all aspects of your development projects. Based on our extensive market and regulatory know-how we can support you in the definition of suitable user requirements and guide you through a slim and effective development and registration process.

We optimize your hardware incl. electric systems under economic and ecological aspects. With our vast knowledge of the component market, we reduce your production costs by selecting the right suppliers with you and support you in “make-or-buy” decisions.

We guarantee reliable and high assurance Medical Software Development in accordance with IEC-62304. Additionally, we also support in software documentation according to the standard requirements.

The success of any medical device is increasingly more dependent on modern design and excellent usability. We assist you in optimizing this important aspect and increasing the safety of your product.

With usability engineering, we ensure that your product is user-friendly and that potential user errors will not lead to device failures. We gather feedback directly from the target audience, allowing improved user retention and simultaneous product advancement.

With our knowledge of applicable standards such as IEC 60601-1-6 or IEC 62366, we are also offering the creation of usability files.

With our advanced understanding of medical devices, we are your perfect partner to analyze your machine or developed prototype. We provide assessments of the hardware concept, software architecture, functional safety, usability, graphical-user-interface, instruction of use and service manual, and so on.
We also present extensive and detailed reports based on the results of our SWOT analysis.

Regardless of whether you need support with the approval of a medical device, the fulfillment of national or international regulations, or communication with the notified body, D.med Consulting GmbH is at your side and provides you with comprehensive support. Furthermore, we are experts in quality management related aspects and can assist you to establish a quality management system as ISO 13485 in your company.

Our key focus is to improve patient care, treatment effectivity, usability, cost-reduction and more. With our proper planning, sound strategy, and a versatile team we transform innovative ideas into reality.

R&D

Consulting

Our development team will support you in delivering your product to the market with their extensive domain knowledge and advanced resources.
We perform strategic market research and analysis. We also establish distribution structures to support you in the management of product certifications and analyzing and filling of the patents.

Clinical Trials for the Success of your Products
D.med Consulting’s dedicated team includes experts in the field of medical practice and clinical studies. We develop study designs and support you in managing and monitoring your the studies in an organized way.

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Gerd Breuch

Gerd Breuch

Chief Technology Officer

“We are passionate about extracorporeal therapies, especially renal replacement therapy. Using our expertise in innovation, quality, efficiency, and cost-optimization D.med develops state-of-the-art technology for dialysis patients.”

Gerd Breuch

Chief Technology Officer

Gerd Breuch

“We are passionate about extracorporeal therapies, especially renal replacement therapy. Using our expertise in innovation, quality, efficiency, and cost-optimization D.med develop state-of-the-art technology for dialysis patients.”

References

Some Selected Projects

Renal Engineering

D.med
Surdial X

As the lead developer of the Nipro Surdial-X, we enabled Nipro Corporation Japan to introduce a high-end, state-of-the-art Hemodialysis machine to the international market and created optional features like Kt/V measurement, blood volume measurement, monitoring, optimized substitution flow control, etc.

Tradename/Product of Nipro Corporation® Japan

D.med
Nephroflow

The D.med NephroFlow, an advanced access-flow, and recirculation measurement system, is the latest product of D.med Healthcare in the field of dialysis. It was developed in close cooperation with German-based emtec GmbH, a technology leader in non-invasive flow measurement.

D.med Technical
System (DTS)

DTS is a service software developed by D.med to track your medical devices, interventions (e.g. repairs, maintenance and safety inspections), customers and measurement tools. With its user-friendly interface and a logical workflow that enables an intuitive handling, DTS simplifies administrative processes, documentation and technical surveillance.

Guidance & consulting
for new MDR

We support customers adapting to the new Medical Device Regulation (MDR). That support includes the modification of any documentation and technical files as required. Additionally, we can consult you in the execution of new required processes.

Monitoring & Database
Software for Dialysis Clinics

Development of medical software to manage patient data and dialysis prescriptions. This software allows users to store patient-related data and dialysis prescriptions in a smart database. Allowing the clinic staff to monitor parameters live during dialysis treatment. Additionally, the software tracks laboratory results, vital parameters, and medications.

dmed-angel

Focus on Quality

Advanced quality management is the key driver to guarantee outstanding treatment results independent from local reimbursement rates. That is why D.med Consulting GmbH shows a certified quality management system according to DIN EN ISO 13485:2016.

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Forschung_und_Entwicklung_2018_print_en

Locations

R&D Consulting

map

Hamburg, Germany
– Technical Headquarter
– Development
– Project Management

Düsseldorf, Germany
– Global Headquarter

Malaga, Spain
– Software & Electronic Development

Skopje, Macedonia
– Clinical Trials