Medical Technology WAREMA plastics engineering and mechanical engineering Visions. Solutions. WAREMA.
Plastics. Material. Engineering. A special class of solutions Contents Plastics engineering and mechanical engineering 3 Medical technology segments - Pharmaceutical 4 - Medical devices 4 - Diagnostics 5 - Life sciences 5 Product development & realization 6 Cleanroom 7 2
As a subsidiary of the WAREMA Renkhoff SE group, we cover a broad area of operations. Alongside the sun shading and automotive industries, medical technology is a major focus of our work. When developing products in this segment, we can rely on the extensive know-how offered by the entire company group. It is a source of potential that creates extraordinary opportunities. For innovative solutions that set quality and functionality standards in their fields of application. WAREMA Renkhoff SE WAREMA International GmbH WAREMA Sonnenschutztechnik GmbH Wings Professional Project GmbH WAREMA Kunststofftechnik und Maschinenbau GmbH WAREMA Austria GmbH WAREMA France SARL WAREMA Iberia S.L. WAREMA Korea Yuhan Hoesa WAREMA Nederland B.V. WAREMA Schweiz GmbH WAREMA Sun Shading Systems (Shanghai) Co., Ltd. WAREMA Plastic Technology Hungary Kft. Our product philosophy The collaboration between all of our divisions is one of our most important principles for achieving customer satisfaction. Our road map for reaching this goal includes comprehensive production plans, assurance through analysis methods, and the pursuit of an erroravoidance strategy rather than error correction. Quality goals We set clear objectives, which can be summed up as follows: 100% quality 100% of promises kept 100% of customers happy Cleanliness, orderliness and reliability are essential factors in this process. Our positive work environment promotes the creativity and the CIP of our employees. 3
Medical. Technology. Pharmaceutical Hygienically clean: Our pharmaceutical components are manufactured to be particle-free. In addition, we apply anti-bacterial materials as a finish and perform efficacy tests to ensure that our products are completely free of microorganisms. On request, we can sterilise your products before use. Medical Handled cleanly: As a system supplier for subassemblies, dialysis machine components or signal transmission in operating room support systems, we make sure that the daily routine at the clinic is a smooth one. Here, flawless hygiene is just as critical as error-free performance which we ensure with our standard-compliant production and process validation. 4
Diagnostics All round accuracy: To provide undistorted measurements, many diagnostic methods require components that are free of DNA/RNA. Not only do our products satisfy this requirement, they also comply with all other applicable hygiene standards. In addition, they are manufactured in precision production processes, guaranteeing dimensional accuracy and optimal performance. Life sciences Measure better: More and more people are looking to measure their health-critical medical indicators, such as blood sugar level or blood pressure, at home instead of at the doctor's office. However, there are often significant differences in quality among these home-use devices. We manufacture subassemblies of superior quality, allowing users to obtain accurate measurements. 5
Product. Assurance. Reliable realization of innovative ideas Precision down to the last detail As a full-range supplier, WAREMA offers a comprehensive spectrum of services, ranging from conception to the finished product. On request, we can also handle the management of your entire project. Our components are manufactured in compliance with legal hygiene and quality standards, as well as ISO 13485. From the very beginning, product assurance plays an important role: before we begin designing a product, we perform producibility and risk analyses in accordance with ISO 14971. After passing through the stages of material selection, calculation and simulation, prototype construction, and product-specific component testing, the product finally enters the series production phase. All of our processes can be validated as required under FDA 21 CFR Part 820. 6
Clean. Room. Strict standards are our norm Perfect hygiene, straight from the factory With our ISO class 7 cleanroom (certified to GMP D), we satisfy the incredibly demanding hygiene requirements that apply to the manufacturing, assembly and packaging of medical devices. Our cleanroom is integrated into a 600 m 2 controlled area. We also combine hygiene with precision: our fully electronic injection-moulding machines offer operational accuracy down to thousandths of a millimetre. For a perfect product in every respect: medically, technically and hygienically. 7
WAREMA Kunststofftechnik und Maschinenbau GmbH Dillberg 33 97828 Marktheidenfeld www.warema-kunststofftechnik.com info.plasticsengineering@warema.com