There’s a growing need for medical software as healthcare progresses to be more accessible to patients in emergencies and regardless of location. Telehealth apps, diagnostic tools, and electronic health records are some of the common ones that already help patients and practitioners save time. These are very sensitive products, and a single error in a diagnostic tool can lead to treatment errors or even lawsuits.
That’s why developers looking to expand into a global market need to be thorough with localization. That would mean adapting software to different languages, respecting local regulations, and also meeting user expectations. Here’s why medical software localization is important, the elements that matter most, and best practices to prioritize.
Why Medical Software Localization Matters
The medical industry’s main goal is saving lives, and that extends to everything from doctor-patient relationships to software development. Regardless of the area of medical interaction, clear and accurate communication is non-negotiable. That also makes medical localization a necessity in every market. Here’s why developers looking to scale their software can’t afford not to localize:
Patient safety
Patients can only use software as intended when it comes with accurate terminology. A seemingly simple misinterpretation can lead to misdiagnosis, fatalities, and legal action that could damage your company’s reputation. As many as 80% of medical errors were found to be due to miscommunication.
The stakes are really high here because it’s easy to miss a misinterpreted term in a diagnostic tool manual, for instance. With non-local translators or tool-based translations, terms can be translated on a word-for-word basis, leaving out the context, which is most important. The only way to completely avoid it is to use medical translation services that actually have local translators who also understand the field.
Regulatory compliance
Medical software must meet strict compliance requirements in every market to ensure safety, avoid legal issues, and facilitate successful global launches. If you’re entering into the US, European, and other global markets, you’ll come across regulatory agencies and standards such as these:
FDA: The Food and Drug Administration is part of the U.S. Department of Health and Human Services, responsible for protecting public health. They ensure the safety and efficiency of health-related products like medical devices, food supply, and medicine.
EMA: In Europe, there’s the European Medicines Agency, which is a decentralized agency handling the scientific evaluation of monitoring of medicines and medical devices.
ISO 13485: An international quality management standard that defines requirements for medical devices and related products.
EU MDR (Medical Device Regulation): A regulatory framework establishing safety, labeling, and performance requirements for medical devices in the European Union.
Compliance with these agencies, standards, and frameworks ensures that medical software is safe, reliable, and market-ready. Proper adherence helps prevent errors in labeling, documentation, and product functionality. According to the 2025 Sedgwick Recall Index, Class I medical device recalls increased to 10.8% in 2024, up from 7.7% in 2023—showing how noncompliance or documentation errors can lead to significant market setbacks.
User experience
No matter how easy-to-use the software looks, doctors, nurses, and patients need intuitive and localized interfaces. Developers need to understand what icons, word choices, or overall designs work best per country or region as a whole. Users shouldn’t have to guess what specific features or menu items are for simply because they aren’t in their local language or don’t use symbols they know.
Key Elements to Localize In Medical Software
The main utility purpose of your medical software stays the same, so that it can solve the problem it was designed to solve. However, these are key elements that need to be localized so that they are useful to people in your specific target markets:
User Interface (UI)
All buttons, menus, warnings, and on-screen instructions help users understand what to do and what to avoid while using your software. Each one should be accurately labelled in the local language and using elements that are familiar and region-specific. Navigation should also be designed to follow a smooth flow based on what your software is designed for.
User Manuals and Help Files
Guides with clear, accurate, and contextual instructions ensure safe and effective use. Rather than translate a guide from English to Korean word-for-word, a local translator can interpret steps and processes in a way the audience can easily understand and follow.
Medical Terminology
It is important to adapt terms to local clinical and linguistic norms. Even languages with different variants, like UK and US English, can have words or sentences that are interpreted differently. Such differences in meaning should be considered when writing medical terms in documents like manuals and guides.
Units, Measurements, and Formats
Whatever has to do with numbers or measurements needs to be carefully localized. adjusting numerical, date, and time conventions. For instance, while most parts of Europe measure body weight in KGs, the US uses pounds. Such differences also apply to things like expiry dates and preferred times for product use. A single wrong date format could leave a product in the market longer than its validity period.
Regulatory Documentation
Making your software market-ready means getting all the needed approvals as quickly as possible. One of the best ways to do that is to ensure you align your submission to local standards. This includes labeling requirements and fully understanding that language or choice of words is acceptable for use in each document.
Marketing and Training Materials
Users in each region need to feel like your medical software was created specifically for them. Every marketing and training material should be localized to reflect this. Use culturally appropriate and acceptable references, media, and elements.
6 Medical Software Localization Best Practices
To successfully enter and become a go-to medical software brand in a new market, here are 6 software localization best practices to prioritize:
1. Work with Specialized Medical Translators
A regular translator may understand a language but not know medical terms or what they mean. That’s why an industry specialist is a must-have in your localization process. Partner with a translation company that services the medical industry specifically or has medical translators on their team. This saves your business from multiple document reviews, edits, and even product recalls that can be financially demanding.
2. Create and Maintain Glossaries and Style Guides
Your brand should already have a distinct voice, and you want to keep that uniform in all your documents. If you use the word “client” and never use “customer” as a synonym, then add that to your style guide.
Keep a glossary that will help the translator know the accurate terms for parts, devices, actions, and everything associated with how your product works and the people it serves. The translator will have a smoother experience localizing your content, and readers won’t get confused as they interact with your software in any form.
3. Plan Localization Early in Development
One of the biggest software localization mistakes to avoid is waiting till you are set to launch or after launch to localize. Decide on the markets earlier on, and start localizing everything from compliance documentation to product parts and guides.
This makes it easier to handle campaigns, introduce your products to locals, and gauge their reception to guide any needed adjustments. It also helps you get started with licensing and local verifications immediately; documents are requested rather than wasting time preparing them later.
4. Conduct Linguistic and Functional Testing
Linguistic testing is your quality assurance step to evaluate how culturally appropriate your translated pieces are within the live environment. A local medical expert will need to interact with your software, look through all the guides, and confirm that the language is natural and contentually correct. This also ties in to functional testing, where experts test your software to see if it works as it should. It is a simulation of what your real user will experience as they interact with your UI and also a way to see if the service adheres to local regulations.
5. Ensure Compliance with Local Regulations
Understand what is good-to-go in your new market by researching local laws and compliance requirements. Ask questions from regulatory bodies, interact with consultants, and gather enough data. Use the information you get in the planning and creation phase of your software before seeking regulatory approval.
6. Collaborate with In-Country Reviewers
It is also a great idea to find physical reviewers in your new market. A local can identify which product feels relatable and culturally accurate or which features look and feel foreign. That insight can then inform the upgrades or tweaks to prioritize.
Conclusion
Every medical software is a potential life-saving tool, which needs to be as accurate as possible. That’s why localization is important when looking to expand the software’s reach to new countries or locations. Without localization, issues like misinterpretation can cause irreparable damage to both the end users and the developers themselves. Most importantly, to stay compliant and be locally acceptable, a medical translation specialist is super important. The right services make global expansion twice as successful, save revision time, and save product recall losses by up to half.
At EC Innovation, our team of medically trained local translators helps medical software companies stay compliant, prioritizing translation accuracy and cultural relevance. Contact us for support or queries on your medical software localization projects, and we’ll be delighted to assist.
