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Avantpage and EmTex Offer Seamless MDR Compliance Solutions

Avantpage and EmTex Offer Seamless MDR Compliance Solutions

In the dynamic landscape of the life sciences industry, collaboration can be key to overcoming complex challenges and delivering exceptional results. Recently, Avantpage Life Sciences and EmTex Life Science joined forces to address an MDR compliance challenge presented by a leading medical imaging solutions manufacturer. This collaboration exemplifies the power of strategic partnerships in providing comprehensive, one-stop solutions tailored to the needs of our clients in this highly regulated sector.  The client approached Avantpage Life Sciences with a specific request. They needed their most recent Instructions for Use (IFU) translated into five languages, but also needed support with the crucial step of checking MDR compliance with EU standards. As the source text is written at their headquarters in Japan, ensuring MDR compliance with Medical Devices Class 1 EU regulations is essential. The client typically conducts MDR compliance checks in-house but, in this instance, requested that Avantpage include the task in the project scope. Given the crucial nature of both MDR compliance and linguistic accuracy, Avantpage leveraged their partnership with EmTex Life Science to tackle this challenge head-on.  EmTex Life Science, a provider of medical writing and communication services based in Belgium, brought over two decades of experience in regulatory medical writing to the table. Their EU regulatory compliance specialists meticulously reviewed the English text against EU Medical Device Regulation (MDR) standards, ensuring that the content met the necessary requirements.  Once the English text received the MDR compliance stamp of approval from EmTex Life Science, Avantpage’s team of expert linguists translated the IFU into five languages: French, German, Italian, Spanish, and Turkish. As subject-matter experts in the field, Avantpage’s teams ensured linguistic accuracy and cultural nuances were preserved throughout the translation process.  In addition to translation, Avantpage’s graphic design team played a crucial role in the project by reformatting the translated files, ensuring consistency and readability across all languages. The result was a set of IFUs that not only met MDR compliance standards but also provided clear and accessible instructions to end-users in diverse linguistic markets. Beyond delivering the translated IFUs, Avantpage went the extra mile by creating a post-project glossary for use on future client projects and updates.   Avantpage Life Sciences was delighted to partner with EmTex Life Science on this MDR compliance project as our respective company offerings are the perfect complement to one another. Both companies are trusted partners for the life sciences industry, and both are focused on what we know we do best. Avantpage’s linguists are experts in clinical trials, pharmaceuticals, medical devices, and biotech, and the company is ISO-certified. EmTex Life Science brings a wealth of expertise in medical writing and communications services to the table, with writers specializing in preclinical, clinical, pharmacokinetics, pharmacodynamics, and quality of life. Through their EmTex Academy, they also offer professional courses within the life science industry, further demonstrating their commitment to excellence and knowledge sharing.  Client testimonials speak volumes about the success of the collaboration between Avantpage and EmTex Life Science. Sales and Marketing Manager at a global manufacturer of imaging solutions, praised the seamless experience and expressed confidence in Avantpage’s continued support in navigating complex regulatory landscapes. “This was the first time we worked with a different vendor and also the first time we asked an external partner to check MDR compliance. Things were very smooth with Avantpage, who will soon begin assisting with the complex IFU update process.” – Sales and Marketing Manager at a global manufacturer of imaging solutions In conclusion, the partnership between Avantpage and EmTex Life Science exemplifies the power of collaboration in the life sciences industry. By leveraging each other’s expertise, these two industry leaders provided the client with a comprehensive MDR compliance solution that addressed their unique challenges and exceeded expectations. As the life sciences landscape continues to evolve, partnerships like this will play an increasingly vital role in driving innovation, compliance, and success for clients worldwide. 

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AI or Human Translation: A Roadmap for Your Translation Project

AI or Human Translation: A Roadmap for Your Translation Project

In the year since OpenAI launched ChatGPT in November 2022, we humans have been scrambling trying to figure out just what to make of artificial intelligence (AI). No matter the industry you work in — government, medicine, or even language services — the use of AI as a tool has been a hot topic for all of us this year. In the language services industry, we’ve been dealing with AI and translation for even longer now — since the rise of neural machine translation in the 2010s, AI has been an extremely powerful translation tool. But the highly fluent nature of texts produced through modern machine translation tools raises the question: When is human translation better than AI translation, and vice versa? The answer is complicated — it all depends on the type of content you need translated and the specific requirements you have for that translation. That’s why we’ve devised the following roadmap for you to determine whether you should request AI-powered translation, human translation, or a hybrid model for your language services. Here, we’ll take a look at the questions you should ask yourself before determining which approach to use in your translation needs.
The first question you’ll want to ask yourself is about the type of content that you need translated — AI is especially good at translating more technical, repetitive texts, however it still lacks the human touch necessary for more creative types of content, like pun-heavy marketing materials or nuanced blog posts, just to name a couple of examples.  While a human will generally review AI translations before you get the final product, you may find that the translation process goes more smoothly when you start with a human translator from the get-go for certain types of content. You’ll also want to consider some of the specific requirements of the project when you’re wondering which route to go. Here are just a few factors to look at: If you have a tight deadline for a given project and the content type is suitable for AI translation, AI could be the right way to go. AI tends to be much faster, where human translators need more time. That said, if the content type isn’t ideal for AI translation, you may find that the review process ends up taking longer than desired — in cases where your content needs to be translated quickly by a human, consider requesting a rush translation from a trusted language service provider. Human-produced translations are going to cost you more than an AI translation. Still, it’s important to consider the fact that human translations are typically higher quality, and mistakes resulting from an AI translation could be costly. Consider the type of content you need translated first before determining what your budget constraints allow for.
Quality expectations vary across projects — choosing between AI and human translation may also hinge on factors like the expected accuracy, cultural sensitivity requirements, and the project’s potential impact on organizational outcomes and performance. Generally speaking, human translators will be able to ensure more accurate results, as AI often makes errors in vocabulary and context. Additionally, critical content like legal or medical documents demands the precision that human translators provide. AI, while advanced, often lacks the contextual understanding required for such materials. Language service experts often note that AI translates words, not meaning, while humans translate meaning, not words. This is particularly important to keep in mind with texts that may have culturally sensitive information — certain words and phrases might come across bluntly or insensitively when directly translated into another language, and as such, a human translator is important when considering cultural sensitivity. Human translators excel in capturing cultural nuances, ensuring that the translated content aligns seamlessly with the target audience. For projects where translation quality directly impacts outcomes — think educational materials that will assist a patient in their health decisions, or a child’s individualized educational plan that will determine their educational path — investing in human expertise is generally the more strategic choice.
While AI can produce content that meets your voice requirements, human translators are generally much better at creating content that adheres to your style and voice guidelines. A common complaint about AI translation tools is that they can’t consistently account for stylistic requirements — for example, if your brand’s content strictly follows the Chicago Manual of Style, AI may not be able to adequately follow those style guidelines. While machine translation glossaries and adaptive machine translation can be useful for AI translations, human translators still have an edge here. Humans are more well-equipped to translate jargon-heavy or highly stylized texts, and it’s much easier to get them to review and follow your organization’s unique style and tone guidelines.
Because AI-powered translation tools tend to struggle with accuracy more than human translators do, it’s important to consider the risks associated with your project — that is, what could go wrong, and how can you prevent the likelihood of that happening? For highly sensitive content — medical documents, legal texts, and anything else that’s heavily regulated — human translators provide the necessary expertise to navigate complex terminologies accurately. Inaccurate translations of these kinds of texts can be costly, have legal implications, and could even be life-threatening — that means it’s important to work with a trusted human translator who can provide the most accurate translation possible. If you determine that the overall risk is low and opt for machine translation, you can mitigate risk even further by incorporating thorough review and quality assurance processes. Quality assurance tools can perform objective measures of the quality of a given translation, while human reviewers are an absolute must, as they can fill in the gaps in any AI translation. Additionally, user feedback can play a useful role in mitigating the risk associated with AI or human translation. Consider testing out a translation with a small focus group to hear their thoughts on a given translation — this will give you a sample of what end users will think when they encounter the final product, allowing you to tweak details as necessary.
Before you decide to opt for an AI translation tool over a human translator, ask yourself the following questions: Whether or not you use AI or human translation depends on a wide range of factors — and sometimes, the answer still isn’t clear. In those instances, you may find that a hybrid approach works best. At Avantpage, we recognize the value of both AI and human capabilities. Our approach integrates AI features, human expertise, and hybrid methods to ensure a customized solution that works best for your project’s unique demands. If you’re looking to learn more about whether AI translation, human translation, or a hybrid approach is best for your project, contact us today at [email protected] or submit an enquiry. We’ll help you determine and execute the most effective strategy for your project.

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7 Essential Tips for Effective Translation Quality Assessment

7 Essential Tips for Effective Translation Quality Assessment

When you’re looking for a language service provider to translate your content into a language you’re not familiar with, it can be hard to gauge translation vendor quality.  After all, if you’re not a trained linguist who’s literate in the target language, you won’t be able to analyze the final product for linguistic or style errors. And you’ll probably have an even harder time comparing the final translation of one vendor with that of another vendor. Clients seek out language service providers to do what they can’t: translate content from the language they speak into a language they dont speak. But even if you can’t speak the target language, there are still ways to check the quality of your final product—you don’t have to blindly assume that one vendor is the best one for your project simply because they’re more familiar with the target language than you are. Though it may be difficult—especially if you’re new to purchasing language services—you can indeed evaluate translation vendor quality using means other than language knowledge. Here, we’ve identified seven ways that clients can evaluate the quality of translations you’ve commissioned from a language service provider. If you’ve identified a handful of different translation vendors that you could potentially work with, one way to sort out high quality vendors is to ask about the steps of their translation process. Each provider has their own way of doing things. Typically, they’ll start with a basic translation—either conducted by a human translator, a machine translation tool or both. Many providers will follow this with an editing step, and even a proofreading step (this process is typically referred to as TEP, short for “translation, editing, and proofreading”). To make sure that you’re avoiding any misspellings and stylistic or cultural errors, these last two steps are especially important ways to assure a high-quality translation. Be sure to ask what steps are included in the agency’s standard pricing and what are add-ons. There may be additional steps offered at a slightly higher price point, so keep these things in mind as you compare vendors. Did you know: At Avantpage, we use the traditional TEP process, but have added two additional quality check steps at no added cost. Like many other industries, the language services industry has several certifying bodies that evaluate a company’s overall quality. When researching language service providers, check if they advertise their certifications on their website. The American Translators’ Association is well-recognized for their certifications of individual translators and linguists, while the International Organization for Standardization (ISO) has several certifications relevant to the language industry, such as ISO 17100 Translation Services and ISO 9001 Quality Systems Management. Did you know: Avantpage is certified in both the ISO 17100 Translation Services and ISO 9001 Quality Systems Management.  You’ll also want to ask your vendor about their internal quality assurance processes. By doing so, you’ll be able to ensure they have some set of systems in place to maintain translation quality. To start this conversation, you can ask the provider if they have an internally dedicated QA team. If they do, ask them how big the team is and what each person does.  A well-structured QA department indicates that the vendor has a robust system of checks and balances, reducing the likelihood of errors in your translations. Additionally, vendors with internal QA teams, especially those with in-house language experts, may offer cost savings compared to those relying on external freelancers. This level of detail reflects the vendor’s commitment to consistent, high-quality work. Did you know: Avantpage has a dedicated QA department, with on-staff linguistic reviewers to manage quality control and pass savings on to you. Reviews from other clients can provide valuable insights into a vendor’s quality and reliability. Look for feedback on key factors like translation accuracy, adherence to deadlines, communication, and overall satisfaction. Pay extra close attention to reviews or quotes from clients in similar industries to yours, especially if they have similar project types, as their experiences will be more relevant to your needs. If possible, reach out to past clients directly for more detailed feedback. Consistent positive reviews and high client retention rates are strong indicators that a vendor delivers dependable, high-quality work across projects. Did you know: Avantpage shares regular client quotes on our LinkedIn page and on our client website page to help you see what our clients say about us. Language service providers that work in highly regulated industries such as government, life sciences, and healthcare, often have to complete audits for their clients. In doing this work, language service providers are able to document the quality of their work for clients that must comply with the strict regulations of their industry. By asking about their history of audit compliance, you can get a better feel for the provider’s commitment to quality—strong compliance with audits may be indicative of a higher-than-average level of quality. Did you know: Avantpage works annually with many clients to conduct compliance audits so they can adequately meet and report to overseeing organizations. Look into how long your potential providers have been working in the language service industry. The longer a company’s been around, the more likely they are to have established themselves as a high-quality provider. Additionally, look at the different lineup of clients they’ve worked with—if they’ve worked with high-profile clients in your industry (and maintained a long working relationship with them), they’re likely to be a good fit for your needs. Many agencies will provide case studies on their website or on request—these can provide you with valuable information about their clients and their professional relationships. If one case study strikes you as particularly interesting, you can also ask the vendor for more information about it to learn a bit more. You may also like: our Avantpage Case Studies page showcases the work our partners do to meet language access. Lastly, you’ll want to ask what additional checks and balances the vendor uses to maintain their translation quality. Ask them if they conduct regular quality tests on translations, as well as design and formatting if they’re relevant to your project. If they do, be sure to ask how often they conduct these checks, as well as how thorough these tests are. These tests can come in many different forms: internal assessments, surveys of project-level satisfaction, annual customer surveys, and more. Language service providers with structured processes for internal quality review and testing are more likely to demonstrate a commitment to accountability and continuous improvement. When you work with a vendor that employs a thorough set of checks and balances, you can rest easy knowing that quality is a top priority for them, as these measures help ensure that translations meet a consistent standard of quality, regardless of the project size or complexity. Did you know: Avantpage conducts regular surveys to get feedback from clients, and we have rigorous quality testing thresholds to hold ourselves accountable.  When you’re looking for language service providers to help you out with your next translation project, be sure to ask questions and do your research to make sure you’re getting the best quality possible. Though it can be a daunting task to evaluate a provider’s quality—especially if you’re not familiar with the target language—there are several steps a layperson can follow to assess a translation agency’s quality.  Here are seven that we’ve identified to help you out on your search: If you’re looking for a high-quality language service provider to help you out with your next translation project, Avantpage Life Sciences has you covered. We’ve got more than two decades of experience providing translations to clients across a wide range of regulated industries—contact us today at [email protected] or submit an enquiry to learn more.

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