The process of accurately converting documents related to the ISO 13485:2016 standard for medical devices from one language to another is essential for regulatory compliance and global market access. This often includes translating quality manuals, standard operating procedures (SOPs), technical documentation, and labeling information. For instance, a manufacturer seeking to distribute a medical device in Europe must provide documentation compliant with the Medical Device Regulation (MDR) in the languages of the target countries.
Adhering to quality management system (QMS) requirements ensures consistent product quality and patient safety. Accurate linguistic transfer of information in required documentation eliminates ambiguity and misinterpretation, which is crucial for proper device usage and risk mitigation. The ability to market medical devices internationally opens up significant revenue streams for manufacturers, and precise documentation facilitates smoother regulatory approvals, saving time and resources.
