For the EnzySurge management team, Quality Assurance ranks highest in the company’s list of priorities. To this end, we have implemented a system that adheres to the strictest international standards – meeting the requirements of regulatory international laws and in accordance with the regulations of the various regulatory authorities.
The system’s parameters dictate every phase of the design and production processes, and the subsequent distribution of our devices.
We are totally committed to ensuring a consistent level of high quality, while constantly striving to improve all our processes.
EnzySurge maintains QMS (Quality Management System) and Product Certifications for our SilverStream Solution such as:
• FDA clearance (510K)
• FDA Certificate of Establishment
• CDSCO (Indian FDA) clearance
• AMAR (Israeli Ministry of Health) clearance
• Free Sale Certificate from the Israeli Ministry of Health
• ISO - Quality Management System - ISO 13485:2016 & EN ISO 13485:2016
MDITAC (South Korea)
DNDM (El Salvador)
MOH (Palestinian Authority)
Free Sale Certificate from the Israeli Ministry of Health
ISO - Quality Management System - ISO 13485:2016 & EN ISO 13485:2016