Quality Management System
Maintaining the highest standards is essential to our success. We have in place an industry leading quality management system ensuring quality throughout the process.
We are certified in accordance with CE, FDA , ISO 13485:2009 Quality management system for medical devices.
Compliance
Membership
FDA
A QMS controls three managerial processes: quality planning, quality control and quality improvement. ▪ The international standard applicable to the design, production, installation and servicing of medical devices is ISO 13485 Medical devices quality management systems – Requirements for regulatory purposes.
CE
The CE Mark is known as a symbol of quality by many users, the CE certificate is a mark that indicates that the products will not harm human life and property, plant and animal existence and the environment if they are used for their intended purpose, in other words, the product is a safe product.
ISO-13485
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
ISO-9001
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
