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Kahle, a custom machine supplier, also provides a complete line of “standard” equipment built to each individual client’s requirements and product designs. Machines to assemble Syringes, Needles, Tubing Sets and IV Catheters have become “standard” machines due to the number of machines Kahle has built for each product and the years of experience Kahle has of manufacturing machines for each device.
With the advent of safety device legislation and new product design throughout the Medical Device Industry, Kahle has designed and built a wide range custom equipment for the more intricate and demanding standard and safety Medical Devices, developing machines for some of the highest profile products in the industry, for some of the largest Medical Device Manufacturers in the world.
To respond to the intricate demands of Medical Device designs, Kahle unprecedented adaptability and flexibility enables us to utilize the latest in Continuous Motion, Indexing, Asynchronous, Robotic, Mechanical, and Pneumatic material handling and assembly technology to develop, design, and manufacture the most robust and reliable assembly operations for any given Medical Device.
Revolutionary vision inspection systems and custom built leak and occlusion test applications; provide Kahle with internal control of the crucial inspection processes and a critical advantage over all our competition in validation and inspection of each component and sub-assembly during the manufacturing process.
All Kahle machines are built to the CE Mark standards for machine construction and safety and facilitate our customers’ compliance with current Good Manufacturing Practice, publicized under section 520 of the Food, Drug and Cosmetic Act. In addition, Kahle provides machine validation services to develop the documentation for the Functional and Design Requirements Specifications, as well as the Factory Acceptance Test, Installation Qualification, and Operational Qualification Protocols, as outlined by the Quality System Regulation contained in Title 21 Part 820 of the Code of Federal Regulations.
For a virtual tour of our factory floor, please click here.
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