Frequently Asked Questions
What does a life science translation cost?
The cost of medical translation can vary depending on the language combination, the subject area, the quality requirements, and the translation process. The basis for pricing is usually a price per source word. There are also pricing models, though, in which costs are calculated per line/page or hourly rate.
If translations are required frequently, the use of Computer-Assisted Translation (CAT) tools can further lead to long-term reductions in translation costs. These tools create and maintain a translation memory (TM) with every translation carried out and can also recognize repetitions within the text. If you would like to find out the price for a specific document, please contact us, and we will provide you with a free, non-binding quote.
What qualifications do medical translators have?
Our approved translators are native speakers of the target language and have a recognized qualification in translation or equivalent degree in the medical and/or chemical domain. They also have at least 5 years of experience in translation in the relevant therapeutic field.
What is the Medical Device Regulation (MDR) and why is it so important?
The Medical Device Regulation (MDR) came into effect in May 2021. It outlines requirements for manufacturers to sell their products in the EU, including the requirement that relevant product safety documents be translated into the language of the target market. Similar regulations, like the FDA in the US, exist globally, necessitating translations for international businesses in the medical technology sector.
These regulations demonstrate how translation becomes a fundamental part of the medical equipment lifecycle, including marketing materials, user manuals, and labeling.
The role of translation service providers in navigating the new MDR regulations cannot be overstated. ISO 13485 compliance further ensures translations that are inherently compliant with MDR standards, offering assurance to manufacturers and service providers.
SeproTec, prioritizes high-quality translations and traceability in all processes, making ISO certifications mandatory.
What is ISO 13485?
The standard ISO 13485 describes the requirements of a quality management system used by medical device manufacturers, importers and distributors.
This standard is aimed not just at medical device manufacturers but also at the suppliers with whom they interact throughout the device’s lifecycle. Translation becomes associated with the medical device as soon as it is exported to other countries, with the need arising to translate its labeling, user instructions, and other marketing materials, to give just a few examples.
SeproTec, a supplier to medical technology manufacturers, has integrated ISO 13485 into its quality management system, demonstrating its commitment to quality in the medical technology sector.
Why is ISO 13485 important for Medical Devices translation services?
This ISO 13485 standard effectively covers the quality processes that must be followed with clients from the medical and diagnostic device industries, as well as the hospital and dental clinic supply industry. It is a system guaranteed by the rigors of an independent external audit, and it focuses on important topics such as safety and excellence—both of which are of particular relevance in the medical industry. If you want to learn more about quality standards, click here.