Device to assist in the internal fixation of IM nails in Orthopedic Procedures.
Our involvement includes building the device specifications, product design and engineering, material selection, building the technical file, establishing and implementing the Quality Assurance System, document control, failure analysis, prototype production, and beta site production.
KALM interfaces with the relevant notified bodies and represents our clients and their products during the initial audit and subsequent regular audits as required. Over the years we have helped our clients achieve ISO9001:2000, ISO13485:2003, and CE approval for their facilities, processes, and products.
Handle for insulin Pen Users
From Concept through Design, Development and Production
A Wheelchair that has dual configuration: everyday & running
Procurement, Assembly and Packaging
Medical Valve Life Tester
From Design to Production
Welding Jig for Production of Highly Accurate Assembly