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Medical Device Translation Services

We help USA businesses thrive in the European marketplace with our ISO 13485:2016 certified translations

We Understand Your Challenges

Expanding into the European Union (EU) marketplace as a U.S. medical devices company presents several translation and localization challenges due to the diverse linguistic and regulatory landscape within the EU, including transition timelines, device classifications, and registration requirements. Here are some of the key challenges you may encounter:

Language Diversity: With 24 official languages across 27 EU member countries, translation into multiple languages is essential for regulatory compliance and effective communication.
Regulatory Compliance: Strict EU regulations, including MDR and IVDR, require translated materials to meet specific EU requirements, such as IFUs and labeling.
Harmonized Terminology: Ensure the use of EU-accepted medical terminology and unit conversions to meet EU standards in translated materials.
Cultural Sensitivity: Adapt content to cultural nuances and preferences in different EU member states.
Units of Measurement: Convert measurements to metric for EU standards in translated materials.
Regulatory Documentation: Translate technical files, risk assessments, clinical trial data, and quality management system documentation in compliance with EU regulations.

Time Considerations: Address the challenges of securing certifications for legacy medical devices within narrow regulatory deadlines.
Authorized Representatives: Provide translated materials for authorized representatives in EU member states.
Post-Market Surveillance: Ensure post-market surveillance materials are accessible in relevant EU languages.
Adverse Event Reporting: Simplify adverse event reporting processes and materials for healthcare professionals and patients.
Localization of Software and User Interfaces: Localize software, user interfaces, and mobile apps to match EU language preferences and cultural expectations.
Training and Support: Offer training and support materials in local languages for proper device usage and maintenance.

We Provide You Precise, Top-Notch Translations

Our high-quality language services are in full compliance with Regulation (EU) 2017/745, ISO 9001:2015 and ISO 13485:2016 Medical Devices Translations & Text formatting and paging for Medical Devices documents standards. Following ISO 17100:2015 Translation Services requirements, we will also provide a Certificate of Accuracy upon request, giving you total peace of mind.

ISO 13485:2016 for Medical Devices

Our ISO 13485:2016 certification for medical devices highlights the critical role translations play in safeguarding the quality of medical devices. While it’s not mandatory, we go the extra mile to instill confidence in our clients. At Intertranslations, we take our responsibility for human life seriously, and our certifications reflect our unwavering commitment to upholding the highest standards.

ISO 17100:2015 Quality Management

Our ISO 17100:2015 Quality Management System certification certification aligned with new regulation requirements serves as a testament to our commitment to excellence. Our team consists of native linguists specializing in life sciences. They bring extensive experience, including roles like physicians, healthcare professionals, and medical device technical writers. We carefully choose experts with a strong track record to guarantee high-quality translations.

Meeting Your Deadlines

We understand the importance of meeting strict deadlines in the medical devices sector. As a translation agency, we recognize that timely and accurate translations are essential for regulatory compliance and quick access to vital medical equipment. Any delay can impede approval processes and impact patient care. Therefore, we prioritize reliability and swift turnaround to uphold the critical needs of the healthcare industry.

Effective Terminology Management

Our TM tools facilitate the creation and management of terminology databases, ensuring consistent usage of standardized terms specific to medical devices. This consistency results in clear communication, which is vital for accurate understanding and regulatory compliance.

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We Translate All Types of Medical Device Documents

MSDS
IFU’s
Product catalogues
Installation manuals
Training booklets

Patents
Device labelling
SOPs
Procedures

We Ensure Regulatory Compliance in Medical Device Translation Services

As an international language service provider specializing in medical translations, Intertranslations has committed since 1996 to assisting leading medical device firms in reaching their regulatory goals and export objectives.
Boasting over two decades of expertise, our team delivers top-tier translation services tailored to fulfill your specific needs.
Do you have any other questions not covered here? We would be happy to hear them and delve into them to provide you with the answers.

FAQs

We have compiled the most frequently asked questions about medical device regulations and provide you with answers based on our extensive knowledge and experience in medical device translations.
Do you have any other questions not covered here?
We would be happy to hear them and delve into them to provide you with the answers.

What is the ISO 13485:2016 Certification?

ISO 13485:2016 expands on the principles of ISO 9001, the global standard for quality management systems (QMS), enhancing safety and reducing costs and legal risks, specifically within the medical device industry. This standard covers all aspects of a medical device’s life cycle, including design, development, production, storage, installation, and distribution. It applies to any organization involved in any part of the life cycle of a medical device, encompassing related services such as maintenance, technical support, and suppliers or external parties providing components to these organizations.

Is ISO 17100:2015 Quality Management System certification compliant with recent regulatory changes?

Indeed, it is. Being an ISO 17100:2015 accredited translation firm, we exclusively hire native language experts who specialize in the life sciences sector.
Our dedicated team of science translators boasts diverse educational and professional backgrounds, including medical practitioners, healthcare workers, and technical authors in the medical equipment field. We carefully choose translators with a demonstrated history of proficiency, thereby guaranteeing the high standard of your translation projects.

Do your original documents include uneditable elements like scans, images, diagrams, and signatures?

Our skilled graphic designers are adept at extracting text from any non-editable documents. Once the text is extracted, it’s forwarded to our translators. The final document is then returned to you with the text translated into the desired language.

Looking for quality assurance and indemnity insurance?

Our 10 million GBP indemnity insurance policy safeguards our services. We’re proud to state that in our 25 years of operation, we’ve never had to make a claim.

Concerned about pricing?

We provide project-based quotes on a per-word basis, excluding repetitions. Our specialized translation management tools identify and eliminate repeated text, ensuring that you’re only charged once for translation of recurring content. We maintain translation memories and glossaries for your projects, allowing us to cross-reference new files with previous translations and charge solely for new content. This approach, combined with our specialized translation software, guarantees a transparent pricing system that helps you manage the cost of your financial translations.