Contract development and manufacturing of medical devices
Medical devices

For medical devices we are a reliable cooperation partner for the development from the idea to series production-readiness that combines innovative strength and industrialization competence. On behalf of our customers, we develop and produce medical devices like, for example, disposable systems for a hemostatic scalp clip system and for artificial respiration. We also manufacture disposables for trocars, components for blood pumps, as well as operation grips of plastics. In the process we specialize equally in fully automated large series production and in the manual and semi-automatic small series production of complex, technically sophisticated injection molding products.

Your PLUS with Gerresheimer

Full service: from the concept development to the finished CE-marked medical device

Contract development and contract manufacturing of medical devices and medical products
Development of operating concepts for a medical device

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 device through assembly to the finished CE-marked medical device: 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 8 and 9, 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 %.

Design for Manufacturing: reduction of development time

Contract development and contract manufacturing of medical devices and medical products
Design for Manufacturing flows into the development of medical devices

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 of made 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.

The tailored production solution for every product

Medical devices, plastic injection molding and assembly
Assembly and application of Teflon to the slipway of a medical device

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.

Premiere class quality audits: FDA-inspected device manufacturer

FDA inspected medical device manufacturer
CentriMag® blood pump system: Audit of the entire value creation chain

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.

Small series production

Small series production, clean room production, injection molding and assembly
Small series production in the clean room according to ISO 14644-1 ISO-class 8

Our Technical Competence Center (TCC) in Wackersdorf (Germany) offers its 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 device is possible at any phase of the project. The TCC possesses a clean room in accordance with ISO 14644-1 ISO-class 8, in which the entire value creation chain can be reproduced.

Worldwide production capacites

Contract development and contract manufacturing of medical devices and medical products
Clean room production in accordance with ISO 14644-1 ISO class 8 in Pfreimd, Germany

We offer production facilities in Pfreimd (Germany), Küssnacht (Switzerland), Horšovský Týn (Czech Republic), Peachtree City (USA), Indaiatuba (Brazil) and Dongguan City (China), which serve our international pharmaceuticals, diagnostics, and medical devices customers worldwide. With a production area of 100,000 sqm, of this around 50,000 sqm of clean room area according to ISO 14644-1 ISO classes 7, 8, and 9, as well as more than 350 injection molding machines, we are one of the leading companies in the industry.

Contact
Contact us!
Stefan Gebhardt
Sales Europe
Phone
+49 9431 639 6259
Shane Anderson
Sales North America
Phone
+1 609 369 1679
Rafael Kollofrath
Sales South America
Phone
+49 9431 639 6162
Mike Nie
Sales Asia
Phone
+86 769 8851 7100 317