Medical Devices

As a full-service provider, Gerresheimer  Medical Systems assumes responsibility for all levels of the value creation chain, from the initial product idea for a medical product / medical device through assembly to the finished CE-marked medical product: Concept development, industrial design, product development, manufacturing equipment design, mold making, automation engineering, large and small series production in the clean room according to ISO 14644-1 ISO classes 7, 8, and 9 and GMP classes C and D, product finishing, as well as manual, partially automated and fully automated assembly, picking and packaging. We assume responsibility for the installation of the entire electronics into the end devices and organize the various purchase parts. In this process we make use of strategic partners subject to regular quality audits and that fulfil our strict requirements 100 %.

We develop your medical device or medical product made of plastics in accordance with user requirement specifications or optimize the component layout of existing customer ideas for injection molding production. The Gerresheimer Medical Systems engineers allow the design for manufacturing to flow into the development of new medical devices right from the beginning. For our customers this means a reduction in the development time, of development costs and of project risk, as the step of plastic-compatible optimization is dispensed with. Our experts for the design and development of medical devices made of plastics attach importance to product-specific requirements like, for example, special gluing techniques for a burr-free, blood-friendly surface, the connection of metal and plastics, as well as the implementation of electronics components.

Irrespective of the number of units and the requirements of the medical device, we offer our customers a tailored production solution. In addition to the fully automated large series production of medical devices, we also realize the manual and semi-automatic small series production of complex, technically sophisticated injection molded products.

Gerresheimer Medical Systems occupies a leading position worldwide in the production of medical devices. This is documented by an FDA inspection resulting in no objections whatsoever and classification as an "FDA-inspected device manufacturer". The audit on the occasion of the production of the "CentriMag®" blood pump system" covered the entire value creation chain. In this case Gerresheimer Medical Systems assumed responsibility for the injection molding, assembly, testing, and sterile packaging in the clean room according to ISO 14644-1 of ISO class 8 and hygiene monitoring in accordance with GMP class D.

Our Technical Competence Center (TCC) in Wackersdorf (Germany) and Peachtree City (USA) offers their own production systems (injection molding machines, project-specific assembly systems like automated joining systems, gluing apparatus or systems for ultrasound welding) on which the quick and uncomplicated production of development samples, clinical samples or small series for your medical product or medical device is possible at any phase of the project. The TCCs possesses a clean room in accordance with ISO 14644-1 ISO-class 7, 8 and GMP classes C and D, in which the entire value creation chain can be reproduced.

We offer production facilities in Pfreimd (Germany), Horšovský Týn (Czech Republic), Skopje (North Macedonia), Peachtree City (USA), Indaiatuba (Brazil) and Dongguan City (China), which serve our international medical devices and medical product customers worldwide. With a production area of 120,000 sqm (1,300,000 sqft), of this around 60,000 sqm (670,000 sqft) of clean room area according to ISO 14644-1 ISO classes 7, 8, 9 and GMP classes C and D, as well as more than 350 injection molding machines, we are one of the leading companies in the industry.

Together with a leading diagnostics company, we in the meantime develop and produce lancing devices and lancets for blood sampling in the fifth device generation. In order to enable low-pain blood taking, we have optimized nearly all components of the lancing devices in the last 15 years. Starting with increasingly fine needles, which hardly injure tissue and ensure quick wound healing through a precise feed of the lancets to the ergonomic optimization of the lancing devices, all innovations are aimed at increased user-friendliness and thus at an improvement in compliance.