Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, FDA Registered, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
RAUMEDIC is a leading developer and manufacturer of systems and components. In addition to this, we are a partner for the global medical and pharmaceutical industry. Through the development of innovative diagnostic and acute therapy systems, we contribute significantly to preserving the quality of life and to restoring health in those who have been struck ill.
We provide our customers with innovative and high-quality polymer products from extrusion, injection molding and assembly – all from a single source. In addition, RAUMEDIC develops and produces high-precision pressure measuring systems with microchip technology for the specific indications of neuromonitoring, urology, gastroenterology and traumatology for use in clinics and private practices.
RAUMEDIC’s experienced research and development and engineering teams develop and manufacture customer specific products in four facilities in Germany and in the USA.
RAUMEDIC has its own worldwide sales network and is represented in selected markets by its own distribution companies.
RAUMEDIC has significant manufacturing know-how in the areas of extrusion, precision injection molding and assembly of medical components and systems.
Our own design department in combination with various possibilities for the production of prototypes and pre-series parts, as well as serial tools guaranties a tailored realisation of customer ideas, in an economic product and production concept. Our own material compounding facility for customizing materials to exact customer requirements and customer specifications completes the portfolio.
With available extrusion techniques RAUMEDIC is able to produce multilayer tubing with up to 4 different materials, as well as the production of micro tubing with radiopaque stripes or the production of multi lumen tubing with up to 13 lumens. In the field of micro extrusion RAUMEDIC produce tubing with a dimension of 0.10 mm and a wall thickness of 0.04 mm. This corresponds to the thickness of a human hair (0.04 mm – 0.12 mm).
RAUMEDIC injection molding stands for smallest dimensions, tightest tolerances and crucially functional requirements for individual customer needs. RAUMEDIC annually produces several million molded parts with weights between 4 mg and 200 g. RAUMEDIC’s multi component injection molding techniques, over-molding and insert molding, as well as fully automated assembly systems enables RAUMEDIC to produce complex customer specific products.
For further processing of our tubing and components RAUMEDIC has wide ranging assembly possibilities e.g. punching, printing, thermoforming, assembly/ bonding, packaging and microchip technology. Our product portfolio varies from common cut length, tubing sets and catheters to electronic measuring instruments.
In close cooperation with physicians RAUMEDIC develops and manufactures high precision pressure measurement systems with microchip technology and a plethora of accessories for the fields of Neuromonitoring, Urology and Traumatology.
Finally, RAUMEDIC offers you a one-stop development and manufacturing program for medical tubing, injection molding and full contract manufacturing services. Our engineers will work with you to advise on materials, design and construction, together with packaging and sterilization. We are able to offer full regulatory support to enable you to CE mark your medical device.
Customer satisfaction and adherence to all relevant legal and official requirements are at the center of the company’s approach to quality. The basis for this is given with clean-room production according to ISO 14644 class 7 (10,000) and a quality management system certified to ISO 13485.
RAUMEDIC constructed a new production center in the US. With the US headquarters with development center and clean room production in Mills River in North Carolina, RAUMEDIC provides its North American customers a local service center. The production started there in January 2016 with more than 50 employees and increase this number gradually to over 100. Furthermore RAUMEDIC has been expanding its German headquarters in Helmbrechts, Bavaria at a cost of around 26 million Euro in 2015.
For more information contact RAUMEDIC
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