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ISO 13485:2003

ISO 13485 is based on ISO 9001 with a focus on the design, development, production and installation of medical devices and related services. This standard emphasizes “maintaining” effectiveness of processes, rather than the “continual improvement” that is stressed in ISO 9001. Requires more documentation, monitoring and measurement of data, risk management processes, stresses the need to “maintain effectiveness” of the system.

How Can Merrill Help?

Merrill is committed to quality and risk management. We are certified to ISO 9001:2008, ISO/IEC 27001:2005, ISO 13485:2003 and compliant to ISO 17100:2015, EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill has over 35 years’ experience in the medical device and diagnostics industries. Our medical linguists’ subject matter expertise is second to none. In medical specialties such as audiology, cardiology, endoscopy, neurology, orthopedics, respiratory physiology, urology and vascular surgery, our expert knowledge ensures accuracy and consistency in terminology, reducing the risk of errors and the need for time-consuming edits.

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