ISO 13485 is an internationally recognized standard that specifies the requirements for a quality

management system specifically designed for medical devices. This standard outlines the criteria

that organizations in the medical device industry must meet to ensure that their products

consistently meet customer and regulatory requirements.

Compliance with ISO 13485 is crucial for medical device manufacturers as it demonstrates their

commitment to quality and safety. It covers various aspects of the product life cycle, including

design, development, production, installation, and servicing. By implementing this standard,

organizations can enhance their processes and minimize risks associated with the manufacturing

and distribution of medical devices.

ISO 13485, is an internationally recognized standard for creating a QMS for medical device companies

anywhere in the world.