QMS

Quality Management System

The BEL Quality Management System

All BEL products and services are developed under BEL’s Quality Management System. This is a regulated environment for the company, in which all steps of product design, development, manufacture, and support are conducted with careful hazard analysis, testing, and documentation. The Quality Management System (QMS) is required for developing medical devices, to support US FDA, Chinese FDA, European CE, and other regulation. By developing all of our products under the QMS, we can assure customers that our hardware and software are both safe and effective.

SOURCERER has received 510 (k) clearance by the FDA.

The Quality Standards that guide BEL’s product development

IEC 60601 - Standards for safety and essential performance of medical electrical equipment

ISO 13485 - QMS compliance to the standard for organizations involved in the Medical Device industry

ISO 14971 - Medical device risk management purposes

IEC 62304 - Medical device software – software life cycle processes

ISO 10993 - 1 Biocompatibility testing


All of the BEL products are developed under BEL's quality system to meet regulatory standards.