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:

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:

• Camera housings for security cameras
• Development of the gear box and interface for a robot that provides motion on two radial axes from one axes of origin

A number of samples of the production tools and test equipment that KALM has produced can be seen below:

• Production files for medical video equipment.
  
• Operating Manuals for Medical Equipment and Machinery.
• Medical Device CE and FDA 510K Documentation.
• Risk analysis using the Failure Mode Evaluation Analysis (FMEA) methodology. For an advanced Colonoscope, Video Rectoscope and Cellular Phone Antenna Production.