Decoding the Intricacies of Life Sciences Localization - VistaTalks Episode 130
In the intricate world of life sciences, the importance of localization extends far beyond mere translation. It’s a critical component that ensures patient safety, regulatory compliance, and the successful global deployment of medical products and services. In this episode of VistaTalks, María Mateos, an expert in localization and life sciences, shed light on the nuances of this field and how companies like Vistatec are leading the charge in providing specialized services that meet the industry’s stringent demands.
Localization in life sciences is not just about language accuracy; it’s about cultural adaptation, regulatory knowledge, and technical precision. As Mateos eloquently puts it, “every single word you translate, patient safety may be at risk.” This statement underscores the gravity of the localization process in the life sciences sector, where the stakes are invariably high.
The life sciences industry is one of the most heavily regulated in the world, which adds layers of complexity to the localization process. Mateos highlights the European Union Clinical Trials Regulation (EU CTR) as an example, which demands a single authorization procedure for clinical trials across the EU, a unified portal for submissions, and the publication of all clinical trial protocols and results.
María Mateos emphasizes the need for specialized linguists to translate lay summaries, which must be done in plain language to be understood by the general public. This specialization and expert knowledge are critical in ensuring that clinical trial information is accessible to all, regardless of their medical knowledge. The conversation also included the Medical Device Regulation (MDR), which broadens the scope of what constitutes a medical device, now including software for medical uses. This expansion means that even low-risk medical devices, which may not have been regulated in the past, now require precise and clear translations. Mateos notes that “with the evolving nature of medical device regulations, translators need to be ready to update translations as regulations change.”
Vistatec, a global leader in localization solutions, embodies the expertise and diligence María Mateos describes. With a deep understanding of the life sciences sector, Vistatec ensures that its localization teams are not just linguistically adept but also well-versed in the regulatory and compliance aspects of the industry. Their approach is rooted in a profound commitment to quality, patient safety, and market access.
For localization buyers, professionals, and global businesses, the insights from María Mateos are invaluable. They underscore the need for a localization partner that is not only up-to-date with the latest regulations but also has the infrastructure and expertise to handle the complexities of life sciences localization. Vistatec’s robust quality management systems, which align with many ISO regulations, including those covering quality standards and information security, make them a prime example of what to look for in a localization service provider.
The life sciences industry is a kaleidoscope of innovation and progress, where medical devices, vaccines, and clinical trials are constantly evolving. However, this evolution brings with it an ever-expanding web of regulations and standards that must be meticulously followed to ensure patient safety and product efficacy. Localization in this context is not merely a linguistic challenge but a regulatory one.
Mateos’s advice to those planning to launch life sciences products in new markets is to ensure that their localization team or partner is on top of all regulations. Vistatec, with its deep roots in the localization and life sciences sector, understands the intricacies involved in translating for this industry. It’s not just about language fluency; it’s about subject matter expertise, regulatory knowledge, and a commitment to quality that transcends borders.
The life sciences industry’s localization needs are unique and demanding. As María Mateos and Vistatec demonstrate, meeting these needs requires a blend of linguistic excellence, regulatory expertise, and a steadfast commitment to patient safety. For those in the industry, choosing a localization partner with these capabilities is not just a business decision—it’s a pivotal step in safeguarding the well-being of patients worldwide.
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We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com