Quality & Compliance
July 29, 2021 2023-07-07 15:19Quality & Compliance
Quality & Compliance
Quality Management System
Compliance
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
SO 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.
