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Some of our trusted customers
Julius Breuch
Managing Director
Gerd Breuch
Management Consultant
Eugen Reger
Director PM, Quality & Regulatory
Annika Kruszona
Managing Director
Andreas Happold
Business Development Director
Sina Bieler
Project Manager
Christian Lange
Head of System Development
Susi Pfullmann
Head of V&V
Mohamed Choukri
Chief Engineer
Rabea Gabel
Test Engineer
Kathrin Kehrle
Head of Innovation and Education
Carina Brieskorn
Risk ManagerAbout Us
Headquartered in Hamburg, D.Med Consulting GmbH (“DMC”) is one of the leading specialists in medical device technologies. From the initial idea to the finished product, we develop new tailored solutions in cooperation with our clients, re-engineer existing medical devices, and prepare your market launch by making use of our great network of partners from different areas.
DMC was founded in 2011. Since 2019 it is a joint venture of Fresenius Medical Care, the global market leader in the field of renal care and dialysis, and D.med Healthcare Group, a global provider of medical services and medical products in nephrology, diabetes, and other fields of internal medicine. We bring together two complementary pillars to provide our clients with a full range of services from concept to implementation.
About Us
Headquartered in Hamburg, D.Med Consulting GmbH (“DMC”) is one of the leading specialists in medical device technologies. From the initial idea to the finished product, we develop new tailored solutions in cooperation with our clients, re-engineer existing medical devices, and prepare your market launch by making use of our great network of partners from different areas.
DMC was founded in 2011. Since 2019 it is a joint venture of Fresenius Medical Care, the global market leader in the field of renal care and dialysis, and D.med Healthcare Group, a global provider of medical services and medical products in nephrology, diabetes, and other fields of internal medicine. We bring together two complementary pillars to provide our clients with a full range of services from concept to implementation.
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Our services
In the event that your organization possesses an independent development department, we extend our
consultancy services to provide comprehensive assistance across all facets of your development projects.
Drawing upon our profound market and regulatory expertise, we offer support in defining suitable user
requirements and guiding you through a streamlined and efficient development and registration process.
With our in-depth knowledge of medical devices, we serve as your ideal partner for analyzing your machine or developed prototype. Our expertise encompasses assessments of hardware concepts, software architecture, functional safety, usability, graphical user interface, instructions for use, and service manuals. Furthermore, we deliver comprehensive and detailed reports derived from the outcomes of our SWOT analysis.
Aligned with your expectations and leveraging our expertise, we undertake the complete
development of your product, spanning from the initial idea to the final registration.
Our specialization lies in the optimization of your hardware, including electrical systems, with a dual
focus on economic and ecological aspects. Leveraging our vast knowledge of the component market,
we effectively reduce your production costs by selecting the most suitable suppliers and offering
guidance in critical “make-or-buy” decisions.
We assure the development of reliable and high-assurance medical software in strict adherence to
IEC-62304 standards. Furthermore, we provide comprehensive support in software documentation,
ensuring compliance with all standard requirements, and offer expertise in cybersecurity projects.
An integral aspect of product development involves conducting comprehensive testing of the
medical device, subjecting it to rigorous scrutiny. Collaboratively, we develop tailored test strategies
for the verification and validation of your medical product. This encompasses analyses of the test
basis, establishment of acceptance criteria, and determination of sample size. From test planning to execution and reporting of test results, we provide steadfast support, aiming to demonstrate the
quality of your medical device.
The success of every medical device is increasingly reliant on contemporary design and exceptional
usability. We provide expert assistance in optimizing this crucial aspect and enhancing the safety of
your product. Through usability engineering, we guarantee a user-friendly interface that minimizes
the risk of user errors leading to device malfunctions. Direct feedback from the target audience
enables us to optimize the product and enhance user retention. Leveraging our expertise in relevant
standards such as IEC 60601-1-6 and IEC 62366, we adeptly create usability files that align with
regulatory requirements and industry best practices.
D.Med Consulting’s dedicated team comprises experts in medical practice and clinical studies. We specialize in developing robust study designs and provide comprehensive support in the management and monitoring of studies with meticulous organization.
For all your needs related to the approval of medical devices, compliance with national and
international regulations, or communication with notified bodies, D.Med Consulting is your trusted
partner, offering comprehensive support. Our expertise also extends to quality management-related
aspects, where we can assist you in establishing a robust quality management system such as ISO
13485, within your organization.
Our key experience areas
Cost reduction of medical devices
If you are seeking to reduce the costs of your medical devices, we are here to support you with our extensive technical and production experience gained from numerous comparable projects. From the initial idea to series production, we provide comprehensive assistance, helping you optimize costs without compromising quality.
Technical assessments & Proof of concept
If you require an external perspective on your existing product or have a preliminary prototype of your new medical device, we are here to assist you. Our expertise encompasses valuable insights spanning usability, system architecture, and more. With a hands-on, pragmatic approach, we
provide comprehensive technical assessments and practical proof of concept to help you gain clarity and make informed decisions.
End-to-end development of your medical device
Do you need support to develop your medical device? Leverage our extensive end-to-end development expertise, validated through numerous successful collaborations with industry leaders in the medical device field. From concept to commercialization, we provide comprehensive support throughout the entire development lifecycle.
Cost reduction of medical devices
You would like to reduce the costs of your medical devices? We support you with our technical and production experience from more than X comparable projects – from idea to series production.
Technical assessments & Proof of concept
Do you need an external view of your existing product or have a first prototype of your new medical device? We help you with valuable insights from usability to system architecture and a hands-on, pragmatic proof of concept.
End-to-end development of your medical device
You need support to develop your medical device? we serve you with our end-to-end development expertise proven in many successful projects with market leaders in the extracorporeal field.
Success Stories
Explore some of our success stories and find out how we have applied our innovation and engineering capabilities to the success of key players in the global medical device industry.
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 developed optional features like Kt/V measurement, blood volume measurement, monitoring, optimized substitution flow control, etc. Tradename/Product of Nipro Corporation® Japan.
NiproSurdial X
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.medNephroFlow
Fresenius 5008S CorDiax and 6008 CAREsystem
D.Med Consulting’s development team has made significant contributions to various projects for Fresenius Medical Care, resulting in the successful development of dialysis machines such as the 5008S CorDiax and the 6008 CAREsystem. With a rich project portfolio encompassing component
development, cost reduction initiatives, technical assessments,
concept development for new features, and sub-component software development, DMC has made significant contributions to the advancement of these projects, enhancing the quality and capabilities of the dialysis machines for improved patient care.
Ex Vivo Lung Perfusion (EVLP)
In collaboration with a renowned manufacturer of Ex Vivo Lung Perfusion (EVLP), we have successfully developed a concept for the next generation of EVLP devices. Our focus was on creating a highly integrated and cost-effective system that prioritizes usability, simplifying the perfusion process. The ultimate goal was to reduce the cost per treatment and meet the growing demand for transplantable lungs, thereby enhancing the quality of life for patients.
NephroFlow
NephroFlow, developed collaboratively by D.Med Consulting and emtec GmbH (a German technology leader in non-invasive flow measurement), is an advanced access-flow and recirculation measurement system designed for the field of dialysis. The device offers precise monitoring capabilities, allowing for enhanced dialysis treatment.
Regulatory Affairs Consulting
Through our Regulatory Affairs Consulting expertise, we have successfully supported a prominent dialysis machine manufacturer in adapting their class 2b product to comply with the new Medical Device Regulation (MDR). Discover the diverse aspects of our regulatory affairs services.
- Conducting a meticulous Gap Assessment to identify the new product requirements.
- Thoroughly updating the technical file to align with the MDR requirements.
- Efficiently managing the implementation of normative mandated tests, including functional safety (IEC60601-2-16), electrical safety (IEC60601-1), and biocompatibility (ISO10993).
- Skillfully creating a clinical evaluation in accordance with MEDDEV 2.7.1 Rev 4.
- Leading the communication with the notified body to ensure seamless compliance.
Nipro Surdial X Haemodialysis Machine
As the key developer behind the Nipro Surdial-X, we have enabled Nipro Corporation Japan to introduce a high-end, state-of-the-art hemodialysis machine to the global market. Our expertise has enabled us to develop a range of optional features, including Kt/V measurement, blood volume measurement, monitoring capabilities, and optimized substitution flow control. The Nipro Surdial-X, a trademarked product of Nipro Corporation® Japan, stands as a testament to our commitment to delivering state-of-the-art technology and advancing the field of hemodialysis.
Monitoring & Database Software for Dialysis Clinics
We have successfully developed a medical software solution for efficient management of patient data and dialysis prescriptions. This software empowers users to store and access patient-related information and dialysis prescriptions in a smart database. With real-time monitoring capabilities, clinic staff can effectively track parameters during dialysis treatment. The software also facilitates tracking of laboratory results, vital parameters, and medications, ensuring comprehensive and streamlined patient care.
Quality & Regulations
At D.Med Consulting GmbH, we prioritize advanced quality management as the cornerstone for delivering exceptional treatment outcomes, regardless of local reimbursement rates. That’s why we proudly showcase our certified quality management system in accordance with DIN EN ISO 13485:2016. The scope of our certification encompasses the contract design and development of medical devices for extracorporeal treatment of blood. This certification serves as a testament that all our development projects and supporting processes adhere to a globally recognized standard of quality, ensuring excellence in every aspect of our work.
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