SeproTec achieves a triple quality certificate for translations of medical devices

agosto 31st, 2021 | Posted by admin in Blog | Traducción - (Comentarios desactivados)

SeproTec Multilingual Solutions has made another breakthrough in its medical translation services, becoming one of the few agencies on the market to receive ISO 13485, ISO 17100 and ISO 9001 certifications.

As a company that provides high-quality multilingual services, at SeproTec we highlight the importance of certifications with different ISO standards, such as 15485, 17100 and 9001. These are essential to validate the translation of medical, scientific and technical content that we offer, showing that they conform to the most rigorous and recognized standards that exist. Below, we explain in detail of what these certifications consist, as well as what each standard includes and what it contributes, both to us and to our clients.

SeproTec achieves a triple quality certificate for translations of medical devices

What does it mean to have these certifications? 

SGS, a world leader in inspection, verification, testing and certification, has awarded SeproTec Multilingual Solutions ISO 13485 certification for its translation services in the field of medical devices.  Health sciences is one of the sectors in which SeproTec is most specialized. We carry out translations of medical content with the highest level of precision, fully aware that errors cannot be tolerated. Lives are at stake.

Having these validations is a guarantee that our work meets the highest standards imposed by the Quality Management System.  This includes the ISO standards that must be met for a maximum service guarantee. In our case, we comply with three of these standards in terms of quality, and one in terms of the environment, ensuring, in each of our projects, the highest level of dedication, effort, precision, responsibility and safety.

ISO 13485 standard for medical devices

The standard ISO 13485 is a quality management system used by manufacturers, importers and distributors of medical devices. A medical device is any instrument, apparatus, device, machine, equipment, reagent for in-vitro use, computer program, material, or other similar or related article, which is intended by the manufacturer to be used on people for a health-related purpose.

It is a standard that is aimed not just at manufacturers of medical devices, but also at the suppliers with whom they interact throughout the medical device’s life-cycle.  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.

This ISO 13485 standard effectively embraces 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 issues of great importance such as safety and excellence. Both of these issues are of particular relevance in the medicine industry.

ISO 17100 and 9001 Standards

These two standards are even more important in translation services. The first one, ISO 17100, specific to the translation sector, lists what requirements for each issue must be met as regards the minimum qualification for translators, management of central processes, availability of resources, data protection and confidentiality.

For its part, the ISO 9001 standard ensures a good relationship between supplier and client through a universal language, as well as the ability to provide a service. We always meet both external and internal requirements within our organization, in addition to following cycles of continuous improvement and respecting other labor issues.

These are all advantages for clients

The benefits of working with an ISO 13485 certified language provider include easy integration of supplier and client quality systems, cost reduction and risk minimization in client audits, and the ability to shorten the qualification processes, significantly reducing the allocation of resources and overhead for monitoring suppliers.

 

Obtaining this latest ISO certification confirms SeproTec’s commitment to the most rigorous and recognized QMS standards applied in the health sciences industry.  Over the years, SeproTec has worked with many leading health sciences organizations, including pharmaceutical companies, biotech companies, medical device manufacturers and CROs, and we currently have 110 active clients in the sector, while in 2020 we translated more than 109 million words for the industry, our best endorsement.

SeproTec Translator of the Month: June 2021

agosto 4th, 2021 | Posted by admin in Blog | Chatting with... | Translator of the Month - (Comentarios desactivados)

Jacek Szoblik is a ‘must translator’ when we deal with a technical translation into Polish, a cat lover and the winner of our June edition of the Translation of the Month  action.

This initiative is our way to way to say thank you! and recognize the efforts of the industry professionals: translators, the driving force behind every translation company’s success.

 

Dzień dobry, Jacek.

You are one of our most regular and trusted technical translators. How did you become interested in this specific field of the industry? Name 3 skills you think are needed to be a good technical translator.

Honestly, it was sort of necessary for me to get interested in this field. I worked at SeproTec Kraków as a reviewer so I had to learn quick to be able to get my job done. When it comes to the 3 skills… These are not really skills but let me answer this way: I think you need a great technical dictionary around at all times. Then, you need to be extra observant when you work to get into this technical texts’ vibe and patterns. When you’re good with the above two, you need to practice and get experience. Then you should be fine!

What are the most common translation problems in Polish, your mother tongue?

I’d say that for me it’s that sentences in Polish can get really long. Sometimes you need to build really elaborate phrases to communicate something that was really concise in English. I wouldn’t call that a flaw in general, though!

Sometimes you enjoy running away to the countryside or woods… That’s so necessary! Do you usually take your work with you or prefer to leave it at home?

Absolutely not! It happens way too sporadically to disrupt my free time with a PC or particularly with work! Probably I shouldn’t even take my phone with me.

We are in love with your cat! It is good to be able to spend time with your pets while working. Can you think of any other benefits you get from being a freelancer?

Well, it’s nice to have some more freedom during the day which obviously isn’t possible when working full-time. On the other hand, sometimes you need to sacrifice your weekend… I’m still wondering which work model is better!

What advice would you give to beginner translators?

Leave your home as often as possible! Work from different locations, move, don’t settle in one place. It may sound like wasting time for moving around but for me it’s refreshing and makes me interact with people.

 

Thanks so much Jacek for your time and good work. We really enjoy working with you! Enjoy your SeproTec hoodie.

 

 

 

When a professional translation is ordered for a website or other medium that has been designed for a specific language, it is typical for problems to arise when fitting the new text into the allotted space. In each language a different number of words may be needed to express the same idea. That is why ideas that we want to convey in French or Arabic usually take up more space than in English or Chinese.

Expansion and contraction of texts

This effect is known to translation professionals, and is called expansion or contraction depending on whether more or less space is taken up. For example, when translating a text from English into French, we know that the translation will expand by about 15% compared to its original version.

Although it is very hard for the translation and the original to end up with exactly the same number of words, the effect can be more noticeable depending on the language of the target readers. Generally speaking, Romance languages use more words and Germanic languages use fewer to convey the same concept.

How do contraction and expansion affect design?

Currently, we live in a highly visual world, in which the text on websites, social media, catalogs and brochures are designed to create a sensation and capture people’s attention within seconds. As result, when we have a very noticeable expansion or contraction phenomenon, the end-product may lose its efficacy and adjustments may be needed to conserve the original emotional impact.

At SeproTec we work with localization experts who help our clients to achieve a balance between translation and design. Their work ensures that the original communication goal is preserved, but they may use more appropriate cultural formulas, considering not only the concepts, but also the feelings they engender or the use of a vocabulary that is more familiar to the target readers.

Thanks to their work we are able to guarantee that the product that the end-client receives is true to the original, not just in terms of content, but also intent and appearance. A very graphic example of this are translations into Arabic: images and text boxes are ordered inversely so that they make sense in relation to the direction in which the text is read.

Other factors to bear in mind

In addition to the unpredictability of the amount of characters in a translation, additional factors, such as compound nouns or character width complicate the management and layout of the text.

Languages like Finnish, Dutch and German represent what in other languages would be a sequence of smaller words as a single long word.

For example, the Spanish phrase “Seguro de Responsabilidad civil de automóviles” becomes “Kraftfahrzeug-Haftpflichtversicherung” in German. Although in Spanish that phrase can be adjusted to fit two lines, in German it cannot be automatically adjusted, which can present a layout challenge.

Regarding character width, for example, “plans” in English becomes “しょくぶつ” in Japanese, occupying much more horizontal space.

How does the work done by localizers affect prices?

Most of the language combinations are priced based on word count in the source text (the original text).  Nevertheless, there are times when pricing is based on the word count in the target language.  Since the variation in word count for a given translation cannot be known beforehand, generally conversion ratios are used depending on the project languages. These are established based on the average increase or decrease of the terms.

The final cost of a project will also depend on other factors, such as the subject and the modifications made by the localizer or layout team.  These are usually estimated in work hours. Nevertheless, it will always be faster and more economic to use our specialists than to hire a separate graphic designer for each language to which a document needs to be translated. Our in-house layout teams ensure that your designs are appropriately adapted, taking expansion and contraction into account.

In conclusion, we can say without a doubt that a good professional translation service will always give clients the results they’re looking for. It isn’t just about quality texts, but also good adaptations of the end-product.