Compliance in Translation: Meeting Regulatory Requirements

In this article

As global markets become increasingly interconnected, organizations must not only speak the language of their customers—but also meet the legal, ethical, and procedural standards of the regions they operate in. Whether it’s GDPR in Europe, HIPAA in the United States, or MDR in the medical devices sector, compliance is non-negotiable.

Translation, often seen as a linguistic task, plays a critical role in regulatory compliance. It ensures that information is clear, accurate, accessible—and legally defensible. But compliance in translation is not simply a matter of correct terminology; it requires a structured, auditable process supported by technology, human expertise, and operational discipline.

At Translated, we work with enterprises, institutions, and regulated industries to align multilingual content with the legal and cultural frameworks of each market. Here’s how compliance is shaping the future of translation—and how to approach it strategically.

Why compliance matters in translation

Translation is directly linked to regulatory exposure. A mistranslation in a medical label, legal disclosure, or user agreement can lead to:

  • Fines or sanctions from local authorities
  • Lawsuits or contractual disputes
  • Safety risks for consumers or patients
  • Damage to brand credibility and trust

Industry-specific compliance

Industry-specific compliance is paramount, particularly for sectors such as healthcare, finance, and legal services, where regulatory requirements are stringent and ever-evolving. Each industry has its own set of standards and guidelines that must be adhered to, and failure to comply can result in severe penalties, including fines and reputational damage.

Finance: Financial institutions must comply with regulations such as GDPR in Europe, ensuring that personal data is handled with the utmost care. Translated’s secure, AI-powered ecosystem is designed to address these challenges head-on, offering tailored solutions that meet the specific compliance needs of the finance industry.

Healthcare: The healthcare sector must navigate regulations like HIPAA in the United States, which mandates the protection of patient information. By leveraging advanced technology, such as TranslationOS, organizations can ensure that their translations are not only accurate but also compliant with relevant regulations.

Legal: The critical need for legally valid documents is addressed through official and certified translations. This approach not only mitigates risk but also enhances operational efficiency, allowing businesses to focus on their core activities without the constant worry of regulatory breaches.

Key regulatory drivers for multilingual compliance

GDPR (General Data Protection Regulation)

Requires that individuals understand how their data is used. Translations of privacy notices and consent forms must be clear, accessible, and localized—not just technically correct.

ISO 17100

A standard specifically for translation services, requiring a defined process, qualified professionals, and quality assurance steps. Certification to this standard is often required in regulated industries.

EU MDR (Medical Device Regulation)

Mandates multilingual labeling, safety, and performance documentation for medical devices in the EU. Non-compliance can delay or prevent product access to market.

Local consumer protection laws

Many countries require key documentation—like warranties, contracts, and safety information—to be available in the local official language(s).

What compliance in translation requires

Qualified human professionals

In regulated content, there’s no substitute for native-speaking language professionals with domain expertise. Our network of over 500,000 translators is selected via T-Rank, Translated’s proprietary talent-matching AI that prioritizes:

  • Subject-matter expertise (e.g. legal, pharma, financial)
  • Certification and compliance experience
  • Proven post-editing and QA capabilities

Audit-ready processes

At Translated, our workflows include:

  • Documented QA steps per ISO 17100 and ISO 18587
  • Version control for all translations
  • Traceable feedback loops and edit histories
  • Human-in-the-loop validation, especially for high-risk content

These are managed in our TranslationOS platform, ensuring transparency from quote to delivery.

Terminology governance

Regulated sectors rely on precise and legally validated terminology. We implement:

  • Custom term bases and glossaries
  • Automated terminology QA in CAT tools
  • Cross-market consistency checks to prevent brand or legal risk

Secure data handling

Especially in medical, legal, and enterprise content, data protection is part of compliance. Translated adheres to:

  • ISO/IEC 27001 security standards
  • Encrypted file transfers
  • Secure, access-controlled platforms
  • On-premise or EU-hosted deployment options as needed

Compliance is strategic, not just operational

As multilingual content becomes core to customer experiences, investor relations, and public trust, compliance is no longer just a back-office task—it’s a strategic function. Organizations that treat translation as a core part of their compliance architecture will:

  • Minimize legal exposure
  • Accelerate product launches across regions
  • Build stronger customer and regulatory relationships

At Translated, we offer compliance-ready localization workflows designed for industries where the cost of mistranslation is simply too high.

Ready to make your translations compliant by design?

If you operate in regulated sectors or high-risk domains, Translated can help you:

  • Build compliant, repeatable translation workflows
  • Select domain-specialized, certified language professionals
  • Integrate AI like Lara to increase efficiency with traceability
  • Meet international standards while speaking authentically to your users

Let’s talk about building a multilingual compliance strategy you can trust.