Hiller Feinwerktechnik und Gerätebau GmbH
Medical Technology · Neumünster
Hiller Feinwerktechnik und Gerätebau GmbH is a medical technology company based in Neumünster, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Hiller Feinwerktechnik und Gerätebau GmbH Address & Contact
Hiller Feinwerktechnik und Gerätebau GmbH Overview
Hiller Feinwerktechnik und Gerätebau GmbH was founded in 1993 and has since established itself as an important player in medical technology. Based in Neumünster, Schleswig-Holstein, the company develops and produces tailored solutions that are used in both medical technology and the analysis device industry. Its expertise in precision manufacturing and device construction enables Hiller to meet the demands of a dynamic market and continuously offer innovative products.
Services and Products
The range of Hiller Feinwerktechnik extends across several product areas specifically tailored to the needs of manufacturers of medical devices. The main services include:
- CNC Precision Machining: Hiller uses state-of-the-art CNC technology to produce highly precise components from various materials. Machining processes such as turning, milling, and drilling are used to ensure accurate processing according to technical drawings.
- Device Construction: The company designs and manufactures special devices as well as complete assemblies used in medical applications. Close collaboration with customers during the design and development phase enables tailored solutions that meet specific requirements.
- Surface Treatments: A special feature of Hiller is the execution of medically approved coatings to meet specific hygiene and biocompatibility requirements. In addition to functional surfaces, aesthetic aspects are also considered to make the end products visually appealing.
By combining technical capabilities and extensive expertise, Hiller Feinwerktechnik can flexibly respond to the diverse demands of the market and successfully implement complex projects.
Regulatory Classification
The medical technology products manufactured by Hiller Feinwerktechnik are subject to strict regulatory requirements. The company is certified according to ISO 13485, ensuring that all processes from development to manufacturing meet the quality requirements of medical technology. This certification is crucial for access to European and international markets, as it strengthens confidence in the quality and safety of the products. Hiller works closely with regulatory authorities and notified bodies to ensure that all products comply with applicable standards and guidelines, which is particularly important for the European market.
Regional Importance
Hiller Feinwerktechnik's location in Neumünster is strategically advantageous for the medical technology industry. Schleswig-Holstein is a growing region for medical technology, and the proximity to significant research and clinical areas such as the University Hospitals in Hamburg (UKE) and Kiel (UKSH) allows for valuable exchange and cooperation. This fosters continuous development and research in medical technology and supports Hiller in staying at the forefront of technological advancements.
Moreover, the company benefits from the robust logistics infrastructure of the region, which offers fast transport options to significant markets in Germany and beyond. The strategic connection to Hamburg Port as well as the A7 and A21 facilitates access to international partners and customers.
Distinctive Features and Innovation Power
A standout feature of Hiller is its focus on innovation. The company continuously invests in new technologies and processes to improve product quality and increase efficiency in production. This also includes the integration of state-of-the-art automation solutions, which not only reduce costs but also increase production capacities.
Another aspect is customer orientation. Hiller Feinwerktechnik places great importance on close collaboration with its customers to best meet their specific requirements. This partnership approach allows the company to respond flexibly to market changes and develop innovative solutions that reflect the latest technological advancements.
More medical technology companies: Medical Technology Overview | Medical Technology Schleswig-Holstein | Contract Manufacturers
Frequently asked questions about Hiller Feinwerktechnik und Gerätebau GmbH
What does Hiller Feinwerktechnik und Gerätebau GmbH do?
Hiller Feinwerktechnik und Gerätebau GmbH is a company in the medical technology sector based in Neumünster. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Hiller Feinwerktechnik und Gerätebau GmbH located?
Hiller Feinwerktechnik und Gerätebau GmbH is headquartered in Neumünster. More information can be found on the company's website.
In which area of medical technology is Hiller Feinwerktechnik und Gerätebau GmbH active?
Hiller Feinwerktechnik und Gerätebau GmbH 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.
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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.