Smart Soft Ltd. has received ISO 13485 certification under KIWA

January/27/2020

Smart Soft Ltd, developer of automated MRI lumbar spine assistant system, today announced that the company has received ISO 13485 certification under KIWA. This certification indicates that the company’s Quality Management System meets the regulatory requirements specific to the medical device industry.

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485 Quality Management Standard for Medical Devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

Smart Soft’s ISO 13485:2016 certification scope includes: Design, development, marketing and sales of medical software for radiology, neurology, orthopedics and surgery departments.

This ISO 13485:2016 scope indicates that Smart Soft has established the Quality Management System that is an important milestone achievement towards CE Mark and to meet customer and international regulatory expectations. This ISO 13485 certification and scope verifies the Quality Management System designed to ensure the highest quality product development and manufacture of CoLumbo software. The ISO 13485:2016 certification is an internationally recognized standard for the medical device industry.