What is a Certified Medical Translation

Introduction

Many clinical trials these days are global in nature.  Patients recruited into the trials, as well as the researchers conducting the trial in their country of origin, usually do not rely on English as their primary language.  As such, the importance of translating and localizing clinical materials, so the data can be gathered, researched, and made available across borders is now a vital necessity.

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While there are many reasons why certified translations are important for clinical trials, two in particular stand-out:

• Accuracy issues that compromise the investigators ability to ensure patient safety and care
• Compliance with legal and regulatory requirements in the countries where the trials are being completed

In this blog, we will explain what a Certified Medical Translation is, the difference between Certified and non-Certified translations, and the many specific reasons that it matters.  We will also delve in detail into the three ISO standards relevant to medical translations, known as the gold-standard of certifications.

What Is A Certified Medical Translation?

When a medical translation is “Certified”, it refers to the process of translating documents by a qualified linguist with a medical background, who provides a signature once the translation is completed vying for its accuracy with medical vernacular, as well as its completeness. This written confirmation serves as a guarantee that the translated document is an accurate representation of the original, both in acceptable medical terminology and contextual relevance.

What Is A non-Certified Translation?

According to Motoworld, non-certified translation converts text from one language to another without official certification. While it preserves meaning, tone, and intent, it lacks the validation required for legal or regulatory purposes.

Non-certified translations work well for informal settings, where the primary goal is basic communication rather than compliance or accuracy verification.

As such, medical researchers should prioritize certified medical translations, as translation errors can jeopardize patient safety, cause regulatory delays, and lead to unexpected compliance costs. Accuracy and certification ensure that medical documents meet strict industry standards and support safe, efficient research and healthcare operations.

Why Certification Matters?

There are many benefits:

• Accuracy and Reliability: Subject matter expertise in both target languages is necessary to ensure that medical documents are translated accurately. This reduces the risk of errors that could lead to serious health consequences.
• Legal and Regulatory Compliance: Most countries require translated medical documents to comply with the local regulatory standards. This is necessary so that all medical information is correctly interpreted and contextually relevant to the local population, and adheres to the healthcare regulations of the country.
• Patient Safety: Accurate translations are essential for patient safety. Misunderstandings or errors in medical documents can lead to incorrect diagnoses, treatments, or medication dosages, potentially harming patients.
• Professional Standards: Setting high standards for medical translators, including local knowledge of medical terminology and ethical practices delivers accurately translated complex medical terminology, and the perceived understanding this terminology can have in the country where it is being translated.
• Trust and Credibility: Helps build trust with patients, healthcare providers, and regulatory bodies, and demonstrates a commitment to quality and professionalism in handling sensitive medical information.
• Confidentiality: Appropriate training to handle confidential medical information with the utmost care, means a high regard for patient privacy and data security.

ISO Certification Process

According to Abroadlink, ISO standards are international standards that establish formal requirements, and require a strict certification process:

1) Through these certifications, companies can demonstrate their commitment to internationally recognized quality standards and good management practices.

2) Third-party certification bodies conduct regular audits to verify that the organization continues to comply with ISO standards and to renew certification.

3) ISO certifications can offer several benefits to companies, such as improved efficiency, reduced costs, increased customer and employee satisfaction, regulatory compliance and improved brand image.

ISO certifications are known as the gold-standard, as companies that are ISO compliant need to maintain their standards on an on-going basis.

There are three specific ISO standards relevant to the medical translation industry.

1) ISO 17100:2015 standard specifies the requirements for translation services, including the skills required for translators, the translation and revision processes, and the tools and technologies used to ensure the quality of translations.

2) ISO 13485:2016 standard is applicable to providers of services related to medical devices, including medical translation. This standard aims to ensure the quality and safety of medical devices, and includes requirements for documentation management, process validation, traceability and risk management.

3) ISO 9001:2015 standard requires the implementation of a quality management system that ensures customer satisfaction and the consistent quality of products and services provided.  The lack of quality, accuracy and consistency of medical translations can have serious consequences for patients’ health.

Conclusion

Certified medical translations serves as a critical safeguard, ensuring that linguists have subject matter expertise, a deep understanding of medical terminology, and knowledge of ethics and local context. This expertise guarantees that medical documents remain accurate and meaningful across languages.

Accurate translations are also a key success factor in the timely and cost-effective execution of global clinical trials.

As a trusted translation partner, Language Scientific stands out as the only interpretation company with the LEPnetwork™ (Language Expertise Program), connecting 6,000 expert linguists worldwide.

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