Ingenieurbüro Trosien
Medical Technology · Lübeck
Ingenieurbüro Trosien is a medical technology company based in Lübeck, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Ingenieurbüro Trosien Address & Contact
Engineering Office Trosien at a Glance
The Engineering Office Trosien, founded in 2010 by Dipl.-Ing. Jens Trosien, has established itself in recent years as a competent partner in the field of medical technology development and consulting. Based in Lübeck, Schleswig-Holstein, it offers tailored support for medical device manufacturers in the phases of technical development, documentation, and regulatory compliance according to the European Medical Devices Regulation (EU-MDR). The office has particularly specialized in the specifics of national and European regulations, ensuring that its clients' products are not only functional but also legally secured for market entry.
Services and Products
The Engineering Office Trosien offers a wide range of specific development services for electronic and mechanical medical devices. The core services include:
- Development of electronic and mechanical components: Trosien develops individual solutions that meet the specific requirements of medical technology and integrate state-of-the-art technologies.
- Preparation of technical documentation: As part of the development process, the office ensures that all technical documents required for the approval of a medical product are precisely and comprehensively created.
- Risk analyses according to ISO 14971: Conducting risk analyses is a central service. The Engineering Office Trosien helps medical device manufacturers identify potential risks early and take appropriate measures for risk mitigation.
- Consultation on CE marking: The CE marking is a crucial criterion for market access in Europe. The engineering office supports its clients through targeted advice to ensure that the products meet all necessary requirements and can be safely placed on the market.
The office primarily targets small and medium-sized medical technology manufacturers who often have limited resources yet wish to develop innovative products. Through close collaboration and individual support, it is ensured that the specific needs of these companies are always the focus.
Location Lübeck / Schleswig-Holstein
Lübeck, a city with a long history in healthcare and medical technology, offers an excellent environment for companies in this industry. In particular, the University Medical Center Schleswig-Holstein Campus Lübeck (UKSH) and the University of Lübeck, which offer degree programs in medical informatics and medical technology, play a significant role. These academic institutions are not only sources of highly qualified professionals but also potential cooperation partners for the Engineering Office Trosien. The close connection to research projects and innovation initiatives in the region supports the continuous development of technologies and services in medical technology.
The unique geographical location of Lübeck, near Hamburg, provides additional opportunities for networking and collaborations. The Engineering Office Trosien leverages these advantages to assist both local companies and international clients in the development of safe and innovative medical technology products.
Furthermore, the Engineering Office Trosien plays a crucial role in strengthening the economic base for the medical technology industry in Schleswig-Holstein. By promoting innovations and supporting start-ups and established companies, Trosien actively contributes to the development of a strong health technology market.
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Frequently asked questions about Ingenieurbüro Trosien
What does Ingenieurbüro Trosien do?
Ingenieurbüro Trosien is a company in the medical technology sector based in Lübeck. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Ingenieurbüro Trosien located?
Ingenieurbüro Trosien is headquartered in Lübeck. More information can be found on the company's website.
In which area of medical technology is Ingenieurbüro Trosien active?
Ingenieurbüro Trosien is active in the medical technology sector and offers solutions for medical facilities, clinics and practices. You can find the exact areas of focus on the company's website.
More Medical Technology in Lübeck
Medical Technology in Germany
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About Medical Technology
Germany's medical technology sector is one of the most important in the world. With annual revenues of approximately EUR 36 billion and more than 1,400 companies, Germany ranks as the third-largest medical technology market globally (SPECTARIS 2023), after the United States and Japan. The sector encompasses the development, manufacture and distribution of an extraordinarily wide range of products: in-vitro diagnostic (IVD) devices, medical imaging systems (CT, MRI, ultrasound), implants such as hip and knee prostheses, cardiac pacemakers, surgical instruments, hospital beds, wound care products and medical software classified as a Software as a Medical Device (SaMD). In Germany and across the European Union, medical devices must comply with the EU Medical Device Regulation (MDR 2017/745), which replaced the former Medical Devices Directive (MDD 93/42/EEC). Devices are classified into risk classes I, IIa, IIb and III. Higher-risk classes require a conformity assessment by a designated Notified Body (benannte Stelle) before a CE mark can be affixed. The CE mark signals that the product meets EU safety, performance and quality requirements and may be placed on the European market. Key medtech clusters in Germany include the Munich and Nuremberg region in Bavaria, the Rhine-Main area in Hesse, Tuttlingen in Baden-Württemberg (known as the world capital of surgical instruments) and the Hamburg metropolitan area. This directory lists CE-certified manufacturers, distributors and suppliers across the German medtech sector with full contact details.
Germany as a Global Medical Technology Hub
Germany's position as the world's third-largest medical technology market is underpinned by a combination of industrial engineering excellence, a well-funded healthcare system and a highly productive research landscape. The German medtech sector is characterised by a large number of small and medium-sized enterprises (SMEs) that are often hidden champions (Weltmarktführer) in specialised niches. Unlike the pharmaceutical sector, where large corporations dominate, the medtech industry is more fragmented and innovative, with frequent spin-offs from university hospitals and engineering faculties. Key product categories include imaging systems (MRI, CT, X-ray, ultrasound), endoscopy and minimally invasive surgical tools, orthopaedic implants, cardiovascular devices, in-vitro diagnostics, dental equipment, ophthalmic devices, wound care systems and hospital IT and medical software. Germany is particularly renowned for its surgical instrument manufacturing, centred in Tuttlingen, Baden-Württemberg, which supplies operating theatres worldwide. The annual Medica trade fair in Düsseldorf is the world's largest medical technology exhibition and serves as a global industry showcase.
EU MDR Compliance and CE Marking for German Manufacturers
The EU Medical Device Regulation (MDR 2017/745) replaced the former Medical Devices Directive (MDD 93/42/EEC) and has applied in full since May 2021, with transition periods for legacy devices extended to 2028 in some cases. For German manufacturers selling in the EU market, MDR compliance is a legal necessity. The regulation introduced significantly strengthened requirements compared to the old MDD: more rigorous clinical evidence requirements, mandatory post-market clinical follow-up (PMCF), unique device identification (UDI) registration in the EUDAMED database, increased obligations for Notified Bodies, and stricter rules for software as a medical device (SaMD). The risk classification system under MDR uses four classes (I, IIa, IIb, III) based on the intended purpose, duration of use and body contact of the device. Manufacturers must appoint an authorised representative in the EU if they are not themselves based in an EU member state, and they must maintain a quality management system. In Germany, the Bundesnetzagentur and state authorities support MDR enforcement alongside BfArM.
Innovation and Research in German Medtech
Germany's medtech innovation ecosystem benefits from close collaboration between industry, university hospitals (Universitätsklinika), applied research institutes (such as those of the Fraunhofer and Helmholtz networks) and health technology assessment bodies. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) play important roles in assessing which new medical technologies are eligible for reimbursement by statutory health insurance (GKV). This reimbursement pathway, known as the NUB process (Neue Untersuchungs- und Behandlungsmethoden) for hospital technologies, is a key milestone for commercial success in Germany. Innovative devices that receive a positive NUB assessment can be reimbursed at negotiated rates by statutory insurers, providing a significant market access advantage.
Innovation Fields and Future Technologies
The German medical technology sector is driving numerous future fields forward. AI-supported diagnostics and image analysis are revolutionising radiology and pathology; algorithms for the early detection of cancer and cardiovascular disease are increasingly receiving CE approvals as Software as a Medical Device (SaMD). Robot-assisted surgical systems, led by products from Siemens Healthineers, Brainlab and Karl Storz, are improving precision in complex procedures. Minimally invasive technologies, implantable pacemakers and intelligent prostheses with sensory feedback demonstrate the breadth of innovation. Point-of-care diagnostics enables rapid tests directly in the doctor's surgery or at the bedside. Telemedicine and digital patient records promote networking between medical devices and clinical workflows. The Federal Ministry of Education and Research (BMBF) funding programme specifically supports the development of innovative medical technology products through cooperation between industry and universities.
What does the medical technology sector cover?
Medical technology encompasses the development, manufacture and distribution of medical devices, instruments, software and accessories used to diagnose, prevent, monitor or treat diseases. Germany ranks among the world's leading medical technology hubs.
How are medical devices approved in Germany?
Medical devices in Germany and the EU must comply with the EU Medical Device Regulation (MDR 2017/745) and carry the CE mark. Depending on the risk class, conformity assessments by notified bodies are required.
Where can I find medical technology companies in Germany?
Medical technology companies in Germany can be found through industry associations such as SPECTARIS, BVMed or ZVEI, and via the EUDAMED EU database for registered manufacturers. Sanoliste provides a searchable directory of manufacturers, distributors and suppliers across the German medical technology sector.
How many medical technology companies are there in Germany?
Germany has more than 1,400 medical technology companies generating annual revenues of approximately EUR 36 billion (SPECTARIS 2023), making it the third-largest medical technology market in the world. The majority of companies are small and medium-sized enterprises (SMEs), many of which are world market leaders in their niche.
What are the risk classes for medical devices under the EU MDR?
The EU Medical Device Regulation (MDR 2017/745) classifies medical devices into four risk classes: Class I (lowest risk, e.g. bandages, glasses frames), Class IIa (medium risk, e.g. hearing aids, contact lenses), Class IIb (higher medium risk, e.g. infusion pumps, ventilators) and Class III (highest risk, e.g. implantable cardiac devices, neurosurgical instruments). Higher classes require more rigorous conformity assessment by a Notified Body.
Where are the main medical technology clusters in Germany?
Germany's medical technology industry is concentrated in several regional clusters. Bavaria (particularly Munich and Nuremberg) and Baden-Württemberg (notably Tuttlingen, globally known for surgical instruments) are the two strongest regions. Other significant clusters include the Rhine-Main area in Hesse, the Hamburg metropolitan region, the Ruhr area in North Rhine-Westphalia and the Berlin-Brandenburg region.
What is a Notified Body (benannte Stelle) and why does it matter?
A Notified Body (benannte Stelle) is an independent third-party organisation designated by an EU member state to assess whether medical devices meet the requirements of the MDR before they can carry the CE mark. For Class IIa, IIb and III devices, manufacturers must have their quality management system and technical documentation assessed by a Notified Body. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) oversees market surveillance, while several German organisations hold Notified Body status under the MDR.