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.