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Quadrate Multilingual Consultant Pvt Ltd

Medical devices Translation Services

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MEDICAL DEVICE TRANSLATION SERVICES

Medical devices pass through more regulatory standards than any other devices. The European Union, for example, is strict on the technical documents for any machine imported and used in the country. Quadrate offers you professional medical device translation services to break such language barriers and ensure hassle-free medical device usage. With the help of our linguistic and medical experts, we translate all important medical device related documents such as technical documents, regulatory documents, etc, effectively with minimal cost and time. We localize your medical device documents to resonate with your target audiences and help you achieve global success in the medical device industry.

Quadrate is the trusted choice of leading organizations worldwide.

Why Quadrate for your medical device document translation?

The medical sector is a highly regulated industry with several protocols and verifications that need to be followed before getting approved. In order to get prioritized and approved, medically appropriate medical device translations are required, and Quadrate can deliver you just that.

Your documents at Quadrate will only be handled by subject-matter experts, such as doctors, nurses, chemists, etc., with professional experience in the field. They are trained to translate your medical device documents consistent with the intended region’s government policies and regulatory guidelines.

Certified Translation Services

Quadrate medical device translation service is ISO certified, guaranteeing authentic translation across 150 different languages.

AI Integration

Our superior self-learning AI translates your medical device document with extreme speed and under your budget, wasting no resources while performing this task. This highly efficient tool is developed with constant updates and translation memory from previous translated works.

Translation by experts

We assign your documents to medical professionals and trained linguistic experts to translate your medical device content for subject accuracy and relevancy.

Cultural and local regulations coalescence

Our AI is input with cultural nuances and terminologies, and local government’s regulations to translate your medical documents by incorporating native references and verify for any discrepancies in regards to the medical device regulations implemented by government authorities. Our native translators oversee and supervise this task to ensure the machine translation is in accordance.

Types of medical device translation services

We offer a wide array of medical device translation services covering all medical device documents that require precise and accurate translation, and a high level of authenticity and originality similar to the source document to qualify the local government regulation verification. Here are the list of the most common medical device documents translated by us,

User Manuals

Instructions for Use (IFU)

Regulatory Submissions

CE Marking Documents

FDA Documentation

Clinical Trial Documentation

Product Labels and Packaging

Technical Data Sheets

Safety Data Sheets (SDS)

Software and Interface Localizations

Marketing and Promotional Materials

Patent and Legal Documentation

Training Materials

Quality Management System (QMS) Documentation

Service and Maintenance Manuals

With Quadrate, get the professional service you deserve. Contact us today to begin your global expansion.

Legal Translation

Frequently asked Question

What is the cost of document translation?
Document translation costs are typically calculated on a per-word basis, with rates varying depending on the target language. Additional factors influencing the total cost include required services such as formatting, the number of pages, and other specific needs.
What is a certified translation of a document?
A certified translation is a translation accompanied by a signed statement from a language service provider (LSP) affirming the translation’s accuracy and validity. This statement also includes the translator’s qualifications. Certified translations are often required for legal documents such as birth certificates, death certificates, business contracts, and other legal documents.
What does a certified translation document look like?
A certified translation document includes the translated text along with a signed certification statement. This certification, which verifies the accuracy and validity of the translation, can be provided either electronically or in hard copy form.
What standards should a language service provider have?
A reputable language service provider should hold relevant ISO certifications for quality management systems. These standards ensure high-quality service and reliability. Our certifications include:

– **ISO 9001:2015:** A general quality standard applicable to businesses of any size.
– **ISO 17100:2015:** Specifically designed for translation service providers.
– **ISO 13485:2016:** Tailored for the medical device industry.
– **ISO 18587:2017:** Pertains to translations produced using artificial intelligence (AI) tools, including machine translation (MT) and neural machine translation (NMT).
– **ISO 14971:2019:** Focuses on risk management for medical device companies.

What is a translation memory and how does it help?
A translation memory (TM) is a database that stores source content alongside its corresponding translations. TMs reduce costs by reusing previously translated word segments, ensuring consistency and quality, and speeding up the time to market. TMs are beneficial for various types of content, including technical documents, software, and website translations.
What’s the difference between sworn and certified translations?
The distinction between sworn and certified translations lies in their authorization. A sworn translation is completed by a translator recognized by a legal or government authority and bears a sworn translation stamp. In contrast, a certified translation includes a certification from a language service provider attesting to the translation’s accuracy and completeness, without requiring the translator to be sworn or legally authorized.