Medical Equipment Standards
The medical equipment industry is affected by a range of regulatory systems, national and international standards, and other requirements. At ECO Corporación Empresarial we offer services that help the entire value chain in the medical industry to understand what they must do to bring equipment into compliance with these international standards.
The most recent version of the ISO 13485 standard was published in 2016. Like other standards, it is derived from ISO 9001 and focuses on the customer with a model of continuous improvement.
Regardless of the equipment, as a medical device manufacturer you have a responsibility to supply consistent, quality products. Medical devices go hand in hand with patients, from supporting minor medical conditions to the ability to save lives. As such, high standards of manufacturing control are required.
Companies that establish and implement an ISO 13485 medical device quality management system realize world-class manufacturing quality in the design, development, manufacture, distribution, and care of medical devices. Registration requires compliance with regulations such as the Food and Drug Administration (FDA), updated Good Manufacturing Practices (CGMP).
