News and Views

ISO 13485 and the new EU MDR 2017/745

Mar 10, 2020

Category: Blogs

The use of international standards to ensure consistent high-quality goods and services has long been an accepted practice. In a recent blog, we addressed 2 quality management standards: ISO 9001, generally applicable to all industries, and ISO 17100 which is specific to the translation industry. Drilling down into the quality management requirements of one of the main industries we support, we’d now like to look at ISO 13485 and its importance related to the new European Medical Device Regulation MDR 2017/745.

What is ISO 13485:2016?

ISO 13485 is an international standard that is specific to the medical device industry. Originally published in 1996, the current version dated 2016 was just reviewed and confirmed again in early 2020. It is widely accepted throughout the world: an official ISO survey showed that ISO 13485 certification was issued to 19,472 sites in 104 countries in 2018. While this standard includes many requirements that are specific to medical device companies, parts of the standard are also applicable to suppliers who provide services to this industry, including Language Service Providers.

Certification to ISO 13485 requires companies to demonstrate the implementation, maintenance, and effectiveness of their quality management system. Instead of focusing on product quality (as in ISO:9001 and ISO 17100), ISO 13485 is based on a process-approach to quality management in which the inputs and outputs of linked processes must be identified and managed, and the associated risks minimized. The responsibility of management in promoting awareness of regulatory requirements is emphasized and the position of a person responsible for regulatory compliance is required.

As with other ISO standards, certification to 13485 is issued by independent bodies based on extensive on-site audits by professional auditors. Surveillance audits are annual and recertification is required every three years.

Why is ISO 13485:2016 important?

Companies certifying to ISO 13485 experience general benefits that include greater operational efficiency, cost savings, competitive advantage and more, as discussed in our recent blog on ISO 9001 and ISO 17100. When selecting suppliers, certification to industry-specific standards like ISO 13485 is an important differentiator: it shows that the supplier understands the regulatory environment of its (in this case, medical device) clients and demonstrates that it meets the same rigorous requirements.

As the transition period to the European Union’s new Medical Device Regulation (MDR 2017/745) comes to an end in May 2020, the importance of supplier certification to ISO 13485 increases. Many aspects of the new MDR are aligned with ISO 13485. While not required by MDR 2017/745, certification to ISO 13485 can demonstrate compliance with some of the new regulatory requirements:

  • The new EU MDR requires the implementation of a comprehensive quality management system. Certification to ISO 13485 can show compliance with this requirement.
  • Supply chain transparency in regards to quality systems and risk management is a major focus of the new MDR. Suppliers will need to support their medical device clients with effective, documented processes that take a risk-based approach to decision-making and management of 3rd party suppliers. Certification to ISO 13485:2016 can demonstrate compliance in this regard.
  • With the transition to the new MDR, supplier auditing becomes more important. Working with a supplier that has a person responsible for regulatory compliance as required by ISO 13485 makes this much easier.

Suppliers to the medical device industry share responsibility for the safety of patients. This includes Language Service Providers, who supply much of the final communication that reaches doctors, technicians, and patients around the world. As a long-time supplier to the medical device industry, OmniLingua understands this responsibility and has been certified to ISO 13485 since 2011 by TÜV SÜD America. To learn more about ISO 13485 and the processes OmniLingua has in place to ensure compliance, contact us today. We look forward to talking to you!

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Trends in Translation: What to expect in 2020

Jan 28, 2020

Category: eLearning

2020 is upon us now. What developments will this new year and decade bring in terms of global language needs? According to a survey, 60% of respondents see a positive or very positive year ahead for the language industry. Let’s look at changes in who will be accessing and consuming information how and with what expectations that will create new localization needs in 2020 and beyond.

Changes to your Language Selection

The use of smartphones and the internet for communication, e-commerce, entertainment and education is exploding in markets with large economic growth like China, Brazil, India and Malaysia, to name a few. Countries with surging youth populations, especially in sub-Saharan Africa and the Middle East represent a rapidly growing consumer demographic. Many people in these fast-emerging markets have low English proficiency and are accessing the content in their native languages. Increased demand for native language support is also growing in Russia with its large population of young, technically savvy internet users and in India, where a growing sector of middle-class entrepreneurs have shifted from using English to local languages to conduct digital business. Languages which should see increased translation and localization demand in the coming years include Indian languages - Hindi, Bengali, Urdu, Tamil, Telugu, Kannada, and Marathi - as well as Simplified Chinese (Mandarin), Brazilian Portuguese, Russian, Arabic, Vietnamese, Indonesian and African languages such as Swahili, Yoruba, Hausa and Igbo.

More Localization of Streaming Content

We can expect localization and subtitling of video content to become an even greater focus of localization efforts. Expanded internet bandwidth has made streaming video content viable worldwide. And, with low mobile device and data costs, streaming video content has also opened the internet to an immense pool of new users, many with low literacy rates. Online videos are being watched by an especially high percentage of internet users in Saudi Arabia and Turkey (95%), China (92%), Mexico, Philippines and Spain (88-87%) and India, Brazil and the US (85%). There is a clear consumer-oriented regional focus of content and language in this channel. In India, for example, about 96% of the country’s 500 million internet users consume Indian languages online and this number is projected to grow.

Expansion of Speech-based Translation

Technology which allows users to interact with their devices and applications by simply speaking to them is booming. The elimination of the need for keyboard input opens the internet to expanded user groups and scenarios. It was widely predicted that by the end of 2020, 50% of all online searches will be performed by voice search (think Alexa and Siri) and that 30% of all browsing sessions will be solely voice-based, without a screen. This may turn out to be a conservative estimate. To support this development, translation and localization will need to focus on speech-to-text and speech-to-speech translation which combine automatic voice recognition, machine translation and voice synthesis as currently pioneered by Google’s Translatotron and Microsoft Azure.

Quality Expectations

The changes described above will more decisively shape users’ linguistic quality expectations than ever before.

  • Speech-to-speech translation: Translation quality is more challenging given the colloquial, nonstandard and informal style of spontaneous speech. Final translation quality also depends on errors caused by the automatic speech recognition. While most users currently accept “good enough” translations, as this technology develops, quality expectations will grow.
  • eLearning: The greater the academic focus of eLearning programs, the more important conventional definitions of translation accuracy will remain. In eLearning programs that are more skills-oriented or informal (using chatbots, for example) it will be less important for the localized version to align directly to the original source language.
  • eCommerce: as online global marketing strategies become more mature and refined the transcreation of content will become more important, to ensure that brand messaging is appropriately conveyed to increasingly regional target audiences.

OmniLingua is looking forward to the changes and innovations of 2020 and the new decade. As you examine future global business plans we would be glad to discuss and help you develop language strategies to meet the new challenges ahead.

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What are ISO 9001 and ISO 17100 and why should they matter to your team?

Dec 09, 2019

Category: Blogs

International standards issued by the International Organization for Standardization (ISO) have long been recognized and accepted in the manufacturing world, but have been less widely applied to services like the translation industry. Yet ISO certification can be equally beneficial when selecting and working with language service suppliers.

What are ISO 9001 and the translation-specific ISO 17100 all about and how can they benefit your company?

ISO 9001:2015

ISO 9001 is the international standard that specifies criteria for a quality management system: the collection of policies, processes and records that define how your company creates and delivers your product or service to your customers. It covers the responsibilities of management, the steps of product realization from design to delivery, measurement and analysis of process outputs and management of resources and the workplace. It was first published in 1987 and has been approved by more than 160 countries. The current version of ISO 9001 was released in September 2015.

This standard applies to all organizations, regardless of industry or size. Certified organizations

use the standard to demonstrate their ability to consistently provide products and services that meet customer requirements and to demonstrate their commitment to continuous improvement. More than 875,000 organizations in more than 190 countries were certified to this standard in 2018.

ISO 17100:2015

This is a relatively new official global standard, which as of November 2015 supersedes the old European standard EN 15038. Whereas ISO 9001 is very general and applies to all industries regardless of product or service, ISO 17100 is specific to the translation industry. It outlines the requirements for the core processes and resources necessary for the delivery of a quality translation service that meets client specifications, industry codes and best-practice guides or legislation. It also defines the minimum qualification requirements for human resources (translators, revisers/editors, reviewers, proofreaders, project managers, IT and technology resources) and mandates the safe and confidential handling of data.

Certification to both of these standards is issued by independent bodies based on extensive on-site audits by professional auditors. Annual surveillance audits ensure continuing compliance with the latest updates to the standard.

Why are these standards important?

The benefits of ISO standards have been experienced by companies of all sizes operating all over the globe.

  • Implementation of ISO standards leads to higher operational efficiency and greater quality and consistency of outputs. This leads to cost savings, more on-time deliveries and fewer complaints over time.
  • Certification to these standards simplifies the selection and ongoing qualification of new suppliers. They provide black/white proof of a supplier’s continuing commitment to quality and continuous improvement. Your own ISO audits are easier and faster when you can show that your suppliers are also certified.
  • ISO certification differentiates professional organizations invested in their long-term development and their customers’ needs from fly-by-night companies interested in short-term gains. You will be able to rely on and build long-term relationships with ISO-certified suppliers.
  • The process definition and documentation required by these ISO standards opens up the black box and allows transparency into a supplier’s processes, communication structures and responsibilities. This can simplify the integration of supplier processes into your internal workflow.
  • Process measurement and analysis are required by these standards: an ISO-certified supplier should be able to show you data on the quality of their outputs. This allows you to understand the suppliers’ inputs into your system and make evidence-based decisions.

ISO certification in Practice

OmniLingua has been focused on high quality processes and outputs since the mid 1990s and was first certified to ISO 9001 in 2009. Since then, OmniLingua has been audited annually by the well-respected global certifying body TÜV SÜD and is certified to both ISO 9001:2015 and ISO 17100:2015. To address the specific needs of our clients in the Medical Devices industry, OmniLingua is also certified to ISO 13485:2016, which we’ll write about in our next blog.

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Language in Focus: Ukrainian

Sep 24, 2019


New language law reflects language requirements in flux

Ukraine has been in the news quite a bit lately. Volodymyr Zelensky, a well-known Ukrainian comedian, won a surprise victory in the presidential election this spring and his party went on to win an overwhelming majority in parliamentary elections. Much is in flux in Ukraine and language is playing a role in the country’s political development, as seen in the recent passage of a language law that aims to strengthen and ensure the use of Ukrainian as the official state language.

What languages are currently used in Ukraine?

For centuries before its independence in 1991, Ukraine was part of the Russian Empire and then the USSR. During this time, the Russian language was promoted – often mandated.

As a result of this history, Ukraine is now basically a bilingual country. A survey conducted in March 2017 showed the following distribution of native speakers:

67.7% – Ukrainian
17.4% – Both Ukrainian and Russian
13.8% – Russian
1.1% – Other or Unsure

In this bilingual environment, Ukrainian switches between languages based on:

  • Geographic region: Ukrainian is dominant in the western part of the country; Russian is the primary language in the East and South.
  • Locale: Russian is spoken in big urban and industrialized areas, Ukrainian in villages and rural areas.
  • Situation: Ukrainian is used for formal communication (state institutions, schools), Russian is dominant in business as well as the traditional TV and print media.

As Ukrainization has progressed since the country’s independence, the use of Ukrainian in everyday life has increased. The continuing conflict with Russia has accelerated this trend.

Ukraine’s New Language Law

On July 17, 2019, a law went into effect that protects the Ukrainian language as the only official state language. It does not restrict the use of other languages within Ukraine but aims to ensure the official status, widespread use and ability of all Ukraine citizens and residents to speak Ukrainian fluently.

Relevant sections of this new legislation for business can be summarized as follows:

Websites, Mobile Applications, and Social Network Communications. Businesses registered and selling goods or services in Ukraine must maintain a Ukrainian version of their websites which loads by default for Ukrainian visitors and which is as informative as other language versions. Mobile applications and social network communications of companies providing goods or services in Ukraine must have Ukrainian-language versions.

Software User Interface. Computer software sold in Ukraine must have a user interface in Ukrainian and/or English or another official EU language. Since Russian is not an official EU language, it does not fulfill this requirement. Applications installed on products sold in Ukraine (for example on consoles, smartphones, etc.) must have a Ukrainian version equal in content and volume to other language versions.

Ecommerce, Advertising, and Consumer Information. Information provided to Ukrainian consumers must be provided in Ukrainian by default even when duplicated in other languages.

Print media, Television, and Film. The new law requires that 90% of TV and film content be in Ukrainian and that Ukrainian-language printed media and books make up at least 50% of the total output.

Business communication. Companies located in Ukraine (this includes the Ukraine-based subsidiaries, branches or representative offices of foreign companies) must prepare official business correspondence and employment agreements in the Ukrainian language.

The transition periods for compliance with these regulations range from 2 to 30 months.

Impact on translations and the translation industry

Although much will depend on how consistently the new law is applied, many global businesses active in the Ukrainian market will need to provide Ukrainian translations on a regular basis. There should be an immediate impact on the video game market and online retail sales, where Ukrainian is required but the main language is currently Russian. Dubbing and subtitling services should also be in greater demand since the new law stipulates 90% of TV and film content in Ukrainian. Over time, more software installed in products will need to be translated into Ukrainian since Russian versions no longer fulfill the requirements and most Ukrainians are not fluent in English as a second language.

The new law could also lead to greater standardization of the Ukrainian language. It establishes a National Commission on Standards for the State Language with the power to approve language standards, including terminology and spelling. Depending on how this commission proceeds, their work can have a favorable impact on translation consistency and quality measurement, while requiring attentive maintenance of existing translation memories.

Over the past decade, Ukrainian has become one of the standard translation languages for many global companies. Established language service providers like OmniLingua have teams of experienced Ukrainian linguists located in-country with their fingers on the pulse of their evolving native language. For a more detailed discussion about the impact of this new law on your business, give us a call. We would be glad to provide further information and help you with your future Ukrainian translation needs!

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Global Competitive Advantage

Jul 23, 2019

Category: Blogs

Localization strategies for successful global expansion

The time has come! Your new product or service has been successfully launched at home and you’re ready to expand to other global markets. But what’s the best way to approach this in order to avoid costly mistakes and create the maximum competitive advantage?

There are many aspects that need to be considered: which markets to target first, how to set up distribution and sales channels, how to ship goods, and determine salespricing for local markets. One key aspect that is often overlooked - or considered at a very late date - is the role that local language plays. With all the other aspects of a global launch to consider, you may think that you can rely on your English product information and website for a start and get around to translation at a later date. You may want to reconsider!

Localization requirements

In many cases, the decision whether or not to translate your product and user information is not up to you: it is mandated by local government regulations.

For highly regulated industries, translation of specific information is generally mandated. For example, as we wrote in our March 2019 blog, the new European Union Medical Device Regulation requires that regulated medical device content must be available in all 24 official languages of the EU Member States where the devices are distributed. China and Japan have strict general translation requirements for foreign countries seeking to enter their markets. And as one of our clients recently discovered, Québec has specific requirements for Canadian French translations. To avoid last-minute stress and expense, it is important to check regulatory requirements regarding language when preparing your global product launch. Your Language Service Provider can help you with this.

Market Advantages of Website Localization

You may hope to save time and money during your global launch by waiting to localize your website at a later date. If so, you will be losing access to many new potential buyers.

English is still the most popular language online, but it represents only 25.4% of worldwide internet users. China has by far the most internet users (731 million as of March 2017), followed by India with over 462 million internet users. Although some of these users, as well as many other global internet users, understand English, studies have shown that the vast majority of consumers prefer to buy from websites that are in their own language. In 2014, a survey by Common Sense Advisory found that 56.2% of consumers say that finding information online in their own language is even more important than price. Think of all those customers you are potentially missing out on, just by not having your website available in local languages!

Localization Strategies

So how can you incorporate localization into your global launch strategy?

  1. Budget. When choosing target markets, including localization costs in your ROI analysis. Discuss your plans with your Language Service Provider to get their input on the appropriate localization processes and obtain accurate cost and time estimates.
  2. Research. For each target market, base your localization strategy not only on regulatory language requirements but also research on customer linguistic needs and cultural expectations. You don’t want to make decisions based on assumptions. As Common Sense Advisory recently stated: “Offering translated versions of products and services means little to local customers if your underlying assumptions and designs stray too far from their expectations. Why? Because smart local and regional competitors will benefit from your lack of diligence and either block you from the start or rush in to fill the void.”
  3. Planning. Include localization considerations in the global launch roadmaps of all stakeholder groups, for example:
    • Marketing should address local branding and product names.
    • Regulatory needs to complete submission packages in the local language.
    • Technical Documentation needs to prepare existing content for translation: simplify syntax, grammar, and vocabulary, remove local idioms.
    • Production needs to consider the placement of locale-specific safety warnings. Coordinate project schedules with your Language Service Provider to ensure efficient translation processes and reduce time to market.
  4. Translation. Have stakeholders collaborate with your Language Service Provider on the translation of product information and marketing material, and localization of software, websites, and apps. As appropriate, a good Language Service Provider will adapt content to the target market to create an authentic look and feel, avoid local cultural taboos and (for websites) incorporate locale-specific keywords used by search engines most popular in the targeted markets. A post-translation feedback loop, with verification or review of the translation by native-speaking stakeholders in the target market, will ensure that your content has been rendered appropriately.
  5. Post-launch customer support. Create a plan and a system for collecting and responding to customer-generated data or requests. This might include incorporating native-speakers in your call center, implementing simple machine translation for online inquiries or creating additional locale-specific user information in the target market language.

There’s a lot to think about when venturing into the global marketplace. You have specialists and experts to provide financial, technical and marketing support. A good Language Service Provider will be able to help you with language-related aspects.

OmniLingua would be glad to provide further information and discuss your plans in more detail. Just contact us. We look forward to talking with you!

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Ingenuiti Announces New Location in Barcelona, Spain

Jun 20, 2019

Category: Press Releases

New Office Accommodates Rapid Growth in European Market

Ingenuiti, a leading translation and multimedia services company that optimizes training and communication content for all audiences, is continuing to expand; this time in the form of a new office opening in Barcelona, Spain.

Ingenuiti and its wholly-owned subsidiary OmniLingua have long served many European-based companies, and establishing a local presence to more effectively support their needs was essential. The new Barcelona office will operate as a hub for Business Development, Account Management, Project Management, and Software Development.

“Ultimately, this business decision was all about being close to our customers. Ingenuiti has seen a surge in demand from global organizations with European operations. Having a regional presence enables Ingenuiti and OmniLingua to more proactively communicate, plan and strategize with some of our key accounts in Europe. Additionally, we see this move as a base for expansion in the broader marketplace,” said Adam Eling, Vice President of Client Services.

“We knew the time was right, based on company growth, client needs, and trajectory. We wanted to ensure that we had the right location selected and the right personnel in place to open the office and establish our company culture and ethos. Barcelona is a great fit as we already had a foothold with some remote employees. With a reputation of high quality of life and lower cost of living, Barcelona is a hotbed of diversified business talent. This is a great new chapter for the company and we are excited about the positive impact this location will have for clients and partners,” noted Maarten Fleurke, CEO & Founder of Ingenuiti, LLC.

The Barcelona office officially opened the week of June 3rd, with key team members starting their roles in the new location throughout the month of June. The office will be comprised of a core team of legacy employees, as well as new hires.

About Ingenuiti

Ingenuiti is an industry-leading translation, learning and multimedia services provider whose solutions drive improved performance and global communications for corporations and NGOs. With a full spectrum of custom learning solutions and robust translation/localization capabilities, organizations have come to rely on Ingenuiti to solve their most critical training and global communications challenges. An ISO-certified company, Ingenuiti is unwavering in its commitment to quality, continuous improvement, and passion to facilitate our clients’ success. For more information, please visit and follow us on Facebook, LinkedIn, and Twitter.

About OmniLingua Worldwide, LLC

OmniLingua Worldwide, LLC provides translation, localization, and technology solutions to major clients in the life sciences, automotive, heavy equipment, and manufacturing industries. Founded in Chicago in 1980, OmniLingua’s corporate headquarters are now in Cedar Rapids, Iowa. The company is ISO 9001, 13485, and 17100 certified and has a long-tenured staff and worldwide network of linguistic partners who provide professional translation services to clients. Follow us on Facebook, LinkedIn, and Twitter.

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Marketing Translation vs. Transcreation?

Apr 23, 2019

Category: Translation Blogs Localization

You’ve just spent a lot of time and money on a new marketing campaign that is creative, witty and exactly captures your company’s brand message. You’ve tested and launched it in your home market and now you want to extend the campaign to other countries. How do you ensure that your core message is successfully captured in other languages? Is a standard translation process good enough for this purpose?

Marketing Translation

Marketing translation is a hybrid translation process. Translators are given instructions to focus on the source content, adapting or localizing cultural references, humor, idioms and slang only to the extent allowed by the source. Marketing translation is typically performed for more technical pieces such as catalogs, brochures, and sales sheets or for factual presentations and press releases. For marketing translations many language service providers (LSP) will use teams of translators who represent both the necessary subject matter expertise as well as marketing experience.


Transcreation differs significantly from the translation process: it doesn’t focus on the source text but rather on the concept or message and involves recreating this message in another language, for a different culture or target market. Transcreation is typically performed by multilingual copywriters or linguists specialized in marketing and is recommended for branded messaging: tag lines, slogans, product names, websites, multimedia, and video scripts. Just as the original marketing team needed time to discuss, create, and test the original message, linguists involved in transcreation need to collaborate with client-side marketing teams or agencies to thoroughly understand the marketing message and desired outcome up front and then at the back end to present and explain the transcreated results. Transcreation normally involves more steps, time and money than a marketing translation process, especially when the marketing message is short but far from simple. Taglines and marketing slogans are a good example. Translation of 3-5 words would normally cost pennies and be delivered immediately. Transcreation of a 3-word tagline, however, would be measured in weeks and charged by the hour.

When is Transcreation Needed?

Not all marketing campaigns are highly creative and the need for transcreation instead of marketing translation is not always obvious. Here are some of the aspects to consider in making this decision:

  • Who is the target audience? Are they likely unfamiliar with the language and culture of the source content? Is the intended target market of significant size and value for your company and worth the extra time and money to ensure successful messaging?
  • What is the content type? Is it highly figurative and abstract? Does the source message extend beyond the meaning of the written words?
  • What style is used? Are puns, idioms, or slang used? Does the content use any evolving, trendy language?
  • Are visual images included? Are the images culture-dependent? Do they require adaptation for other markets?

On receipt of a marketing project request, a good LSP will review the source content to determine the appropriate process: marketing translation or transcreation. If transcreation appears to be needed, a good LSP will interact with the client’s marketing team to document the intended goals of the message in a creative brief. Based on this creative brief and using the source text as a reference, the copywriter- linguists will “transcreate” the message to produce target language content that triggers the same emotional reactions as the original content. The results – often multiple alternatives, with back-translations and cultural explanations as appropriate – can then be discussed with client-side marketing teams and local stakeholders to ensure success.

Would you like more information or have a marketing project you’d like to discuss? Contact OmniLingua today. We'd be happy to answer any of your questions and walk you through project steps in further detail.

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How to Prepare for Europe’s Medical Device Regulation 2017/745 (EU MDR): Localization Tips and Best Practices

Mar 08, 2019

Category: Blogs Localization

The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. Device manufacturers who market products in the EU must be ready to meet the May 26, 2020 transition deadline. As the deadline nears, you may be realizing that under the new MDR, language and translations play a much more important role in regulatory compliance than before.

How does EU MDR impact your translation system?

Official Language Requirement: The new EU MDR regulation may change your current language selection requirements. Up until now, individual EU Member States determined their own language selection. This changes under the new MDR, which requires that all regulated medical device content be available in all 24 official languages of the Member States where the devices are distributed. If you haven’t already translated into all 24 languages, this may significantly increase the number of languages you support.

Content requiring translation: The scope of regulated medical devices has been expanded under the new MDR: products with non-medical purposes, such as colored contact lenses, are now included. In addition, translation requirements for devices currently regulated have been modified and expanded to include documentation from the manufacturer, analysis, management, authorization, marketing and distribution of medical devices. In most cases, existing technical documentation will need to be updated or revised to match the new MDR requirements.

Timing of translations: The position of translations in your workflow will probably also be impacted by EU MDR requirements. Under previous regulations, translations were primarily performed after CE marking. Under the new MDR regulations, translations of labeling and Instructions for Use (IFUs) are required as components of the technical dossier that is submitted for review to the Notifying Bodies. This moves the translation of product documentation up in the workflow. To meet new requirements, translation will have to be an integral step in many other phases also, for example post-market surveillance.

Quality Management: The new MDR requires supply chain transparency relating to quality systems and risk management. Your Language Service Provider (LSP) will need to support you with an effective Quality Management System that takes a risk-based approach to decision-making and management of 3rd party suppliers. Although not required, your LSP’s certification to ISO 13485:2016 can demonstrate compliance in this regard.

Translation Quality: The new MDR requires precise, clear language, especially on content intended for the end user. Labeling, IFUs, safety and clinical performance information must be clearly comprehensible and easily understandable to the intended user. This applies not only to the original source language but also to translated content. LSPs must give their translators additional training on this requirement and monitor their work to ensure compliant output.

Content/Translation Management: The new MDR puts a major emphasis on data and use of a central European database of medical devices, EUDAMED, to capture, correlate and exchange device information in all applicable languages. Considering the different types and sources of this information and all the revisions to existing technical documentation required by the new regulation, your LSP must be able to interact with client-based Content Management Systems and have an effective Translation Management System in order to ensure accurate global changes, consistent translations, traceability of work and cost-efficient processes.

How can you make the most of the time remaining?

LSPs like OmniLingua, who understand the new requirements of the EU MDR, will be able to proactively support you in achieving timely compliance with the new regulation. With certified ISO systems in place and trained translators at the ready, we can help you make sure that all of the necessary revisions and updates to existing documentation are applied for all of your EU markets.

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Questions to Ask When Selecting a Translation Provider

Nov 27, 2018

Category: Blogs

In our last blog post we discussed why certification to ISO standards is an important criterion when evaluating Language Service Providers. It functions not only as a globally recognized form of accreditation but shows that the certified LSPs are committed to a quality management system and offer services in line with international standards and industry best practices.

But beyond this basic qualification what else do you need to look for when selecting a new translation supplier? Browsing LSP websites will undoubtedly show that ‘speed,’ ‘quality,’ ‘accuracy,’ ‘punctuality,’ ‘reliability’ and ‘professionalism’ are mentioned more times than you can count. Every reputable LSP has to offer fast, high-quality, accurate, punctual, reliable and professional service. You’ll need to take a deeper look to see which provider best meets your organization’s requirements. Here are some questions to consider:

Does the LSP meet your business requirements?

  • Has it been in business long enough, with the operational and financial stability you require?
  • Is the LSP the right size for your organization and projects? How does its average annual revenue compare to your anticipated spend?
  • Are the LSP’s operations scalable to meet your needs, both in size and geographic location of offices as well as during peak seasons and holidays?
  • Does the LSP support all of the languages you require? All of the services you require?
  • Can the LSP provide good references from other clients and from their suppliers?

Do the services and systems offered match your organization’s level of localization maturity?

  • Are you looking for an LSP that will handle the complete translation process for you or do you have an in-house team that manages translation?
  • Are you looking for a technology offering or do you have your own in-house translation tools and system?
  • Does the LSP offer Machine Translation, if desired?
  • Can the LSP provide the reporting you need?

Are the LSP’s technology systems aligned with your internal systems?

  • Does the LSP support the necessary formats, system and data security requirements? Can your systems “talk” to each other?
  • Does the LSP provide the degree of automation that is right for you?
  • Does the LSP offer the desired level of technology support, consultation and innovation?
  • Are the candidate’s Accounts Receivable & Accounts Payable procedures and technology compatible with your internal requirements?

These questions are by no means universal or comprehensive. They represent a few dimensions that play a role when selecting a Language Service Provider. Your procurement process will need to define the critical services and criterion for your organization to enable selection of suitable potential LSPs.

OmniLingua would be glad to provide further information and discuss aspects of vendor selection with you in more detail. Just contact us. We look forward to talking to you!

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Why work with an ISO-certified LSP?

Oct 03, 2018


We’ve all faced the problem of having to decide who to turn to for help in solving problems: which doctor or lawyer to consult, which hairdresser or tax consultant … This is a fairly easy process if you can look at and judge the results of the work they’ve previously done.

But how do you select a language service provider (LSP)? It’s hard to evaluate the translation quality of a language you and your friends/colleagues don’t understand. How can you know if your carefully crafted safety warnings or marketing messages comes across as intended in a language you do not read or speak? And how can you determine if the LSP’s processes meet your quality requirements?

A good start in selecting the right LSP is to see if they are certified to recognized standards issued by the "International Organization for Standardization" (ISO). There are several ISO standards that apply to the translation industry, ranging from the very general ISO 9001, through the translation-specific ISO 17100 to various standards applicable to other industries which require translation services, such as ISO 13485 and ISO 14971.

Certification to these standards is issued by independent, external organizations based on extensive on-site audits by professional, trained auditors. Annual surveillance reviews ensure continuing compliance with the latest updates to the standards.

There are no guarantees for translation quality, but certification to ISO standards is a valuable method for narrowing down your list of potential suppliers. It provides a clear, traceable system for the accreditation of LSPs. Companies willing to invest the time and effort into establishing and maintaining their ISO certification demonstrate their commitment to a quality management system and offering the best services possible in line with international standards and industry best practices.

So what does this mean in practice? What are the actual advantages of working with a certified language service provider?

  • An ISO-certified LSP knows what they’re doing; their processes are tried and tested, predictable, traceable and efficient. Translation quality is ensured through hard-wired process requirements, including edit or revision of the original translation by a 2nd qualified, professional linguist.
  • Certified LSPs use professional linguists who are trained to capture the nuances of your message in accurate language appropriate to the subject matter and target audience. Documentation of linguists’ qualifications and training should be provided on request.
  • They employ experienced, competent project managers who consistently execute standardized processes and coordinate project communication, relieving the strain on your internal staff. You should be able to step back and monitor your projects’ progress with full peace of mind.
  • A certified LSP's linguists and project managers have access to and are skilled in the use of the appropriate translation management technology and tools to improve translation quality and consistency and to cut project time and cost.
  • ISO standards require high levels of operational security to ensure safe, confidential handling, storage, retrieval, archiving and destruction of data and documents.

And last but not least, if your company itself is also ISO-certified, working with an ISO-certified LSP makes everything easier, from onboarding (fewer hoops and less paperwork) to passing those important internal and external audits. It’s like fitting the pieces of a jigsaw puzzle together rather than pounding a square peg into a round hole.

OmniLingua has had a robust, mature quality management system in place since the mid-1990s. We first certified to ISO standards in 2009. Since then, OmniLingua has been audited annually by the well-respected global organization TÜV SÜD America, and is certified to the following standards:

ISO 9001

ISO 9001: 2015

Requires a quality approach, quality manual, standard processes and a direction to process improvement.

ISO 17100

ISO 17100:2015

Global standard for quality translation service that meets client expectations, industry codes and best-practice guides or legislation.

ISO 13485

ISO 13485:2016

Specific to Medical Device, Pharmaceutical and Clinical translation projects that require the absolute highest level of accuracy and consistency.

OmniLingua just had surveillance audits for all of these certifications in early September. We passed with flying colors, including 2 Best in Class findings.

To learn more about ISO standards for the translation industry and the processes OmniLingua has in place to ensure compliance visit our website or contact us today.

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