KALM’s experience in the development of medical devices includes:
Our involvement in the development has included 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.
Examples of medical devices with which KALM has been involved include:
A disposable rigid sigmoidoscope incorporating a video camera and integral illumination system along with channels for insufflation, irrigation, and surgical procedures.
An extracorporeal vascular access device, consisting of a long term implantable port and disposable connector. We built and managed the design and technical tiles meeting ISO 13485, CE and FDA requirements.
KALM designs and builds electronic enclosures to clients’ specifications. Below are a number of examples:
KALM has worked on the development of a number of products including:
A number of samples of the production tools and test equipment that KALM has produced can be seen below:
Body Armor Penetration Resistance Testing Machine