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.