Areas of expertise


Development of medical devices

Electronic Enclosures

Design and Build to clients' specifications

Product Development

Development of various industry products
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Production of tools


Production of Test Equipment


Documentation for various industries

Medical Devices

KALM’s experience in the development of medical devices includes:

  • Devices for long term implantation
  • Transient invasive device
  • Active devices
  • Disposables
  • Reusable surgical instruments
  • Inhalers


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.

Project: Custom Made Wheelchair

Electronic Enclosures

KALM designs and builds electronic enclosures to clients’ specifications. Below are a number of examples:

  • An electronic enclosure with 5 motherboards for 15 Inserted Cards:
  • RF switch box

Project: Speaker

Project: CHEF iQ Smart Cooker

Product Development

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 robot for testing electronic cards by insertion and removal of the cards using a rack and pinion mechanism

Project: Sole Swipemate Medical

Project: Swipe Mate

Download PDF – Kalm Swipemate Intro.

Kalm Swipemate Intro. 

Production Tools

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

  • Chip Holder for ultrasonic welding

Project: Industrial

Test Equipment

Body Armor Penetration Resistance Testing Machine


  • 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.