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.

The importance of professional translation in the pharmaceutical sector

febrero 23rd, 2021 | Posted by admin in Blog - (Comentarios desactivados)

Translation services are especially important for the medical and pharmaceutical sector. In this article we discuss the advantages of having professional translation services specialized in both clinical research as well as in other specialties in the biopharmaceutical field. Information in this field must be comprehensive and highly accurate in any kind of communication, so the specialization of the translators involved is of vital importance.


Main reasons for using expert translators for life sciences

It is clear that the pharmaceutical sector has a number of characteristics that make it very distinctive, particularly due to the responsibility it holds towards patients. The social impact of the texts translated in this field is huge, so multiple factors must be taken into account in the translation, while also seeking the maximum possible comprehension and accuracy.

Moreover, the pharmaceutical and clinical research fields combine very specialized language with highly diverse registers.  Not only are purely scientific topics discussed, but also legal, informative, administrative, marketing, and other aspects, which are quite specific.

Specificity is the third point that we must consider. This type of translation is highly specialized and makes use of new and technical words that emerge as research progresses. It is therefore imperative that these expert translators are continually learning and renewing their linguistic and conceptual knowledge.

What kind of training do translators who work with pharma and clinical research texts need to have?

First of all, these professionals must have studied a subject that is directly related to the translation. In most cases, this is a college degree in translation and interpreting. However, the industry also includes doctors and researchers specializing in different branches, who, having a high degree of knowledge in a language, can also perform this type of work.

In either case, however, specific medical translation courses are required. This may be through a master’s degree or through studies that, as we mentioned above, must be renewed from time to time to offer maximum precision and accuracy.

In summary, we could say that the four basic characteristics for this type of translator are understanding the specific language related to this sector and the clinical specialty with which they are working, adapting their translations to make them readable, and constantly keeping themselves informed regarding changes in the sector.

Another fundamental point is establishing quality processes that are audited internally and externally to guarantee the quality of the service.

SeproTec has been translating and interpreting content for the healthcare and pharmaceutical industry since its inception, and so it has one of the largest global databases of specialized translators who are trained and experienced in various disciplines related with health and pharmaceuticals. This allows us to guarantee a reliable translation that fulfills the requirements of both the client and sector. Our translators are constantly evaluated by the Vendor Management Department, which also takes care of the comprehensive approval processes for external resources, which go far beyond the requirements of the translation industry-specific quality standard ISO 17100, to which we are certified.

Pharmaceutical translation services in particular, require that experts be hired for the reasons we have presented above. To learn more about our experience in the sector and how we can help you, please do not hesitate to contact us.