Medical Device Translation Services & Localization | ISO-Certified Experts

The cost of medical device translation services depends on multiple factors, including the target language, complexity, and industry-specific terminology. Since medical device document translation involves high precision, regulatory compliance, and technical expertise, the pricing is typically calculated on a per-word basis.

Key factors that influence the total cost of certified medical device translation include:

• Regulatory Compliance Translation – Ensuring adherence to global regulations such as FDA, CE Marking, and ISO-Certified Medical Device Translation standards.
• Technical Document Formatting – Proper structuring of translated content to maintain the original document’s layout and clarity.
• Medical Device Software Localization – Translation and adaptation of software interfaces, user manuals, and medical device labeling translation for international markets.
• Number of Pages & Complexity – Highly technical documents like clinical trial translation services, validated back translation for medical devices, and medical device regulatory intelligence may require additional expertise, impacting pricing.
• Industry-Specific Terminology – Use of precise medical and technical terms for medical and surgical device translation to ensure accuracy and compliance.

At Quadrate, we provide affordable and high-quality medical device translation services with expert linguists and industry professionals. Contact us today for a customized quote and ensure your medical device documents are accurately translated for global markets!

A certified medical device translation is a professionally translated document accompanied by a signed statement from a language service provider (LSP) or a certified medical translator, verifying its accuracy and validity. This certification ensures that the translated content maintains the same technical, regulatory, and linguistic precision as the original document, meeting the highest industry standards.

Why is Certified Medical Device Translation Important?

Certified translations are essential for regulatory compliance translation, ensuring approval by global health authorities such as:

• FDA (Food and Drug Administration)
• EU MDR (Medical Device Regulation)
• ISO-Certified Medical Device Translation (ISO 17100 & ISO 13485)
• CE Marking Documentation
• Documents Requiring Certified Medical Device Translation Services
• Medical Device Regulatory Translation – Compliance documents for global approvals
• Clinical Trial Translation Services – Informed consent forms and trial reports
• Medical Device Instruction Manual Translation – IFUs, user guides, and safety manuals
• Medical Device Label Translation – Labels, inserts, and packaging materials
• Validated Back Translation for Medical Devices – Ensuring consistency and accuracy
• Medical Equipment Translation – Technical documentation for equipment usage

At Quadrate, we offer certified translation for medical and surgical devices, ensuring compliance with international regulatory standards and industry best practices. Contact us today for accurate, ISO-certified medical device translation services tailored to your needs!

A certified medical device translation document consists of the translated text along with an official certification statement verifying its accuracy and validity. This document is signed and stamped by a certified medical translator or a language service provider (LSP) to ensure compliance with regulatory authorities.

Key Elements of a Certified Medical Device Translation Document:

• Translated Medical Text – The document accurately translated into the target language.
• Certification Statement – A legally binding declaration attesting to the translation’s authenticity.
• Translator’s Credentials – Name, qualification, and certification details of the translator or agency.
• Official Stamp and Signature – Authentication from a certified medical device translation provider.
• Compliance Assurance – Verification that the translation meets ISO 17100 & ISO 13485 standards.

How is a Certified Medical Device Translation Delivered?

• Electronic Certified Translations – Provided in a secure, digital format (PDF or encrypted file).
• Hard Copy Certified Translations – Printed, signed, and stamped copies sent via courier.

At Quadrate, we provide certified medical device translation services that meet regulatory compliance translation standards for global approvals. Our translations are accepted by health authorities worldwide, including the FDA, EU MDR, and other regulatory bodies. Contact us today for accurate, ISO-certified medical device translations!

Essential Standards for a Medical Device Translation Service Provider
A trusted medical device translation service provider must adhere to strict international standards to ensure accuracy, compliance, and quality. These standards guarantee that translations meet regulatory requirements and maintain linguistic precision in the medical and technical fields.

Key ISO Certifications for Medical Device Translation Services:

• ISO 9001:2015 – Quality Management System (QMS)
  Ensures consistent, high-quality medical translation services across all processes.
• ISO 17100:2015 – Certified Translation Services

Specifically tailored for language service providers (LSPs), ensuring professional medical document translation by qualified experts.

• ISO 13485:2016 – Medical Device Industry Compliance
  Required for medical and surgical device translation services, ensuring compliance with global regulatory standards such as FDA, EU MDR, and Health Canada.
• ISO 18587:2017 – AI-Powered Translation Compliance

Regulates machine translation post-editing (MTPE) for medical device localization, ensuring AI-driven medical translations meet professional standards.

• ISO 14971:2019 – Medical Device Risk Management
  Covers risk assessment in medical device regulatory translation, ensuring translations align with safety and compliance protocols.

At Quadrate, we provide ISO-certified medical device translation services for medical device documents, regulatory submissions, IFUs, clinical trials, and technical documentation. Our expert linguists and AI-driven translation solutions ensure precise, reliable, and compliant translations for global market access.

Need ISO-compliant medical translation services? Contact Quadrate today!

A Translation Memory (TM) is an essential AI-powered tool in medical device translation services that stores translated content alongside its source text. This dynamic database ensures consistency, enhances quality, and significantly reduces costs for medical document translation.

Key Benefits of Translation Memory in Medical Device Translations:

Cost-Effective Medical Translations
By reusing previously translated content, Translation Memory reduces the need for redundant work, cutting down translation costs while maintaining high-quality standards.

Faster Time-to-Market for Medical Devices

TM enables rapid medical document translations, allowing manufacturers to launch products globally with minimal delays.

Ensures Consistency Across Medical Documents
Ensuring uniformity in technical medical translation services, TM helps maintain accuracy in IFUs, clinical trial translations, regulatory submissions, and device labeling.

Improves Compliance with Global Medical Regulations
Using Translation Memory, translations align with ISO-certified medical device translation standards, ensuring regulatory compliance translation for FDA, MDR, and CE Marking documentation.

Enhances Accuracy for Technical Medical Translations
Medical terminology is highly specialized. TM ensures that medical device localization retains correct terminology across multiple languages, improving clarity and compliance.

At Quadrate, we leverage cutting-edge AI-driven translation memory tools to provide fast, accurate, and cost-effective medical device translation services. Whether it’s medical device software localization, multilingual labeling, or regulatory compliance translation, our ISO-certified translation services ensure linguistic precision and regulatory adherence.

Understanding the distinction between sworn and certified translations is crucial for medical device document translation, especially when dealing with regulatory compliance translation across multiple regions.

What is a Sworn Translation?
A sworn translation is conducted by a government-authorized translator who is legally recognized in a specific country. This type of translation:
Requires an official sworn translator’s stamp.
Is often needed for legal and regulatory documents such as medical device regulatory intelligence reports.
Is mandatory in countries like France, Spain, Germany, and Brazil for medical device labeling translation and other official documents.

What is a Certified Translation?
A certified translation is provided by a language service provider (LSP) and includes a statement verifying the translation’s accuracy and completeness. This type of translation:

Does not require government authorization but follows ISO-certified medical device translation standards.
Is commonly used for clinical trial translation services, medical device software localization, and regulatory submissions.
Is widely accepted in FDA, EU MDR, and CE marking documentation.

Which One Do You Need for Medical Device Translation?
If you’re submitting medical device documentation translation to legal or government agencies, a sworn translation may be required.
If your goal is technical medical translation services for IFUs, regulatory documents, and multilingual content, a certified translation ensures quality, accuracy, and compliance.
At Quadrate, we provide ISO-certified medical translation services, ensuring that your medical and surgical device translations meet global regulatory standards while maintaining linguistic accuracy.