ISO 12007 is an international standard that outlines the fundamental principles and requirements for the documentation of medical devices. Published by the International Organization for Standardization (ISO), this standard provides a unified framework for manufacturers, regulatory bodies, and healthcare professionals to ensure that medical device documentation is accurate, comprehensive, and consistent. By establishing a common language and structure for documentation, ISO 12007 facilitates the exchange of information between stakeholders, enhances patient safety, and supports the development of innovative medical devices that meet global regulatory requirements. By adhering to this standard, medical device manufacturers can ensure that their products are accompanied by clear, concise, and compliant documentation, ultimately contributing to improved healthcare outcomes and reduced risks associated with device misuse.