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Should You Require ISO 13485 from Your Medical Translation Company?

Mar 30, 2022

Suppose you work in the medical device or healthcare industries. To sell your products in international markets, you may be required to translate content, such as user documentation, user interface and software, research documents and marketing materials. Each country has its translation requirements and regulations that are constantly changing and evolving, making it tricky to manage – that’s why it’s essential to partner with a medical translation company specializing in medical device and healthcare translations.

The quality of your translation relies heavily on the medical translation company you choose. These documents require special attention to ensure translation quality and accuracy. Most importantly, the provider you chose to work with should minimally be certified to ISO 13485.

The ISO 13485:2016 Standard

ISO has a standard, ISO 13485:2016, that defines the requirements for a quality management system (QMS) for those companies that are in the medical device industry. ISO 13485 outlines obligations for manufacturers to monitor and control their internal processes and their outsourced processes that affect their product quality. This is where translation and localization companies come in. If a medical device manufacturer outsources its translation process, the manufacturer must be accountable to its supplier. Thus, many large medical companies will also require their medical translation company to have achieved ISO 13485:2016 certification.

That begs the question, ‘is it required for a company that provides outsourced services, such as a medical translation company, to have the ISO 13485 certification?’ Obtaining the certification is voluntary for these types of outsourced services. However, many medical device companies or markets may require it. Every medical translation company or language services provider (LSP) has a different QMS process. To help minimize risk and nonconformance in your final product, their process should be transparent and have answers to questions like: ‘how much experience do you require for linguists,’ ‘do you use termbases/glossaries/ other translation memory tools?’. In addition, it’s important to note that each branch of the translation company must be certified. Be sure to understand what this means for your business needs. Even if you don’t have specific requirements, it’s still a good idea to work with an LSP with the certification.

A Commitment to Clients in the Medical and Healthcare Industries

Suppose a translation company is going to apply to obtain the ISO 13485 certification. In that case, it shows the level of deep commitment the company has to serve the medical device and healthcare markets. To gain accreditation to ISO, a company must meet the strict requirements of the standard, go through a rigorous auditing process and become recertified on a routine basis. It’s a laborious process that requires significant resources and regular maintenance. If the LSP doesn’t have the certificate, the chances are that they currently do not work with any one of the prominent medical companies since most of them will require ISO 13485:2016 from their suppliers. Since obtaining the certification is voluntary, it should make clients feel secure and confident that the company is committed to the medical industry’s high-quality and rigorous standards.

Companies Must Have Thorough Quality Processes

A quality management system refers to the planning, processes, resources and documents to achieve your quality objectives. A QMS can improve operations, reduce waste, lower costs, optimize resources, etc. Since high-quality translations are imperative to the successful release of your medical device, and the gravity of the subject matter, your LSP must have thorough and repeatable processes. When considering an LSP, they may also need to meet ISO 9001:2015. This is an internationally recognized standard that outlines general methods and procedures for maintaining a QMS. It applies to any business in any industry.

A translation supplier with both certifications should have a solid understanding of clients’ quality needs and be able to implement the requirements since the quality foundation is already in place. To obtain the ISO certification and recertify, you must have good management and quality practices. This is the case to get an ISO certification, but it’s even more stringent with the ISO 13485 certification.

Infrastructure Is in Place to Create High-Quality Medical Translations

An LSP with the ISO 13485 certification should have a solid infrastructure. Your LSP’s vetting process should be transparent and require the translator to be a native speaker of the target language. A native speaker understands the languages idioms, terminology, and culture vital in preparing accurate and localized content. They should also have a firm grasp of the source language – this helps ensure that translations are accurate and convey your message in the proper style and tone.

When selecting an LSP, you should look for a life science background and expertise with your product type. For technical medical documents, it’s not enough for translators to have a basic understanding of medical translations — the more specific their subject matter expertise, the better. General familiarity with the medical field is a fundamental requirement. Still, translators with a more profound knowledge of a particular therapeutic area or product application can accurately produce the target language results.

Translation Tools and Technologies Make Processes More Efficient

One of the benefits of having a QMS is that it makes processes more efficient, and translation tools help make that possible. Using the correct language is an essential part of producing high-quality translations. If you don’t already have a comprehensive glossary or termbase specific to your industry and product(s), you should find an LSP that can help you develop one.

Your glossary and termbase can be established before your translations begin or during. Your LSP will create or ensure that your multilingual dictionary comprises essential product, industry, and general terms that are frequently found throughout your source materials. These terms are extracted by a professional terminologist and then translated by a linguist. In-country reviewers will review and approve the terminology added to the termbase (TB). The termbase gets added to each translation project and translation memory (TM) to leverage previous translations. When a translator works on a project, they will see and use the agreed terms throughout the translation and review process.

TM is an essential part of the quality management system provided by your LSP. A translation memory is a repository of original content and the translated versions. Terminology management and glossary tools help maintain consistency across translations while simultaneously lowering costs and time to market. These tools drive process efficiency and bring numerous benefits to clients and the company.

Other Certifications that a Medical Translation Company Should Have

In addition to ISO 13485, it’s beneficial for a medical translation company to have the following two ISO certifications:

ISO 9001:2015 is an internationally recognized standard that specifies quality management standard requirements. It’s intended for any type and size of business.

ISO 17100:2015 is designed for translation providers. It provides requirements for processes, resources, and other necessary things to provide high-quality translations.

Suppose you’re a company in the healthcare or medical device industry. In that case, your vendor will have all three of these certifications because it shows their commitment to high-quality translations, solid internal processes and expertise in the medical industry.


Having the ISO 13485 certification guarantees clients that the language service provider is committed to the medical and healthcare industries and high-quality translations.

Morningside specializes in translation and localization services for the medical device and healthcare industries. Our reputation for thoroughness and quality, the three ISO certifications, and extensive experience working with medical industry leaders make us unique in delivering the highest quality language services. For additional information, I invite you to contact us here.

The international medical industry is highly regulated, so work with a language services provider specializing in medical translations. Medical device and healthcare companies needing translations for global markets should turn to a reputable LSP that emphasizes maintaining certifications or compliance with one or more of the listed ISO standards, displaying commitment to the medical device industry. An LSP specializing in medical translations will know what’s required in each country, help you navigate the requirements, and employ rigorously vetted translators and third-party reviewers for your project needs.

About Us

At Morningside, we’ve been providing high-quality medical translation services for over 20 years, and we have obtained all three of the critical ISO certifications described above. Our quality assurance process includes many layers of controls, including editing and proofing with built-in redundancies. To learn more about our high-quality translations, contact us today.

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