M + S Kunststoffbearbeitung und Systemtechnik GmbH
Medical Technology · Biberach
M + S Kunststoffbearbeitung und Systemtechnik GmbH is a medical technology company based in Biberach, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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M + S Kunststoffbearbeitung und Systemtechnik GmbH Address & Contact
M + S Kunststoffbearbeitung und Systemtechnik GmbH Overview
M + S Kunststoffbearbeitung und Systemtechnik GmbH was founded in 1985 and has since developed into an recognized specialist in the field of plastic processing for medical technology. With a focus on precision and quality, the company has built an excellent reputation over the years. The extensive experience and technical know-how in processing various plastics enable M + S to provide innovative solutions for complex requirements in healthcare and industry. The location Biberach an der Riß plays an important role: It is not only in direct proximity to major companies in the industry but also benefits from a well-trained workforce.
Services and Products
The product range of M + S Kunststoffbearbeitung und Systemtechnik GmbH includes technical components for a variety of applications in medical technology. The services offered include sophisticated injection molding, where high-precision plastic parts are produced in large quantities. In addition, the company also offers machining, a method that allows components to be manufactured with the highest accuracy. The assembly service for complete plastic assemblies ensures that the products are operational and produced in one piece for use.
The quality of the products is ensured through rigorous internal and external inspections, and the components comply with the relevant medical technology standards to meet requirements for purity, biocompatibility, and processing quality. Notably, the continuous investment in state-of-the-art manufacturing technologies allows the company to respond flexibly and efficiently to market demands.
The company has also specialized in the development and production of individual solutions that are tailored to the needs of its customers. This customer-oriented approach has helped establish long-term partnerships with renowned manufacturers in medical technology and pharmaceuticals.
Regulatory Classification and Quality Assurance
M + S Kunststoffbearbeitung und Systemtechnik GmbH operates in a highly regulated environment, which is particularly significant for medical technology. The company has a quality management system that meets the requirements of ISO 13485 – the international standard for quality management systems in medical technology. This certificate attests to the company's commitment to maintaining and continuously improving the highest quality standards. Furthermore, M + S works closely with the relevant regulatory authorities and testing bodies to ensure that all products comply with current guidelines and regulations.
Importance for the Region
M + S Kunststoffbearbeitung und Systemtechnik GmbH plays a central role in the economic landscape of Biberach and the wider region of Upper Swabia. By closely collaborating with renowned manufacturers in medical technology as well as the pharmaceutical industry, the company not only strengthens its own market position but also contributes to the creation of jobs and the training of skilled workers in the region. Especially for engineers and technicians, the establishment of M + S in Biberach offers interesting career opportunities. The local infrastructure, consisting of universities and training institutions, also supports continuous knowledge exchange and the development of new technologies, ultimately benefiting the entire medical technology sector.
More medical technology companies in the region: Medical Technology in Baden-Württemberg or all Medical Technology in Germany on Sanoliste.
Frequently asked questions about M + S Kunststoffbearbeitung und Systemtechnik GmbH
What does M + S Kunststoffbearbeitung und Systemtechnik GmbH do?
M + S Kunststoffbearbeitung und Systemtechnik GmbH is a company in the medical technology sector based in Biberach. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is M + S Kunststoffbearbeitung und Systemtechnik GmbH located?
M + S Kunststoffbearbeitung und Systemtechnik GmbH is headquartered in Biberach. More information can be found on the company's website.
In which area of medical technology is M + S Kunststoffbearbeitung und Systemtechnik GmbH active?
M + S Kunststoffbearbeitung und Systemtechnik 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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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.