Medical software localization reshapes every part of your app. The goal is to make it fit seamlessly into a new healthcare system, regardless of the country and language.
Will the French clinicians read dosage instructions in the units they expect? Will a German regulator raise an eyebrow at an English-only consent form?
Your job is to ensure everything from text and drug units to date formats, error messages, privacy wording—all work as intended and feel native to the user. Miss a single detail and you risk delayed approvals, clinical oversights, or a wave of support tickets from confused practitioners.
⚕️ The simplest guide to medical software localization
This article cuts through the jargon and shows you how to get localization right. We’ll define what medical software localization really covers, explain why it’s non-negotiable for safety and compliance, and show you a couple of real-life examples coming right from Lokalise’s customer pool.
What is medical software localization?
Localizing medical software means making your app feel like it was built for each market. That means adjusting the language, yes, but also the units, workflows, and legal requirements behind the scenes. More often than not, you’d also need to adjust the product itself.
Think about a glucose-monitoring app. In the U.S., it might show mg/dL. But in Canada? It needs to display mmol/L. A German version of your consent form has to meet GDPR standards, not HIPAA. And your diagnostic codes? They may need to align with the local ICD-10 variant, or they won’t make sense to doctors.
Medical software localization is the work that turns a single-market medical app into a safe, compliant global product.
Why localization is critical in medical software
Medical software localization is directly tied to patient safety, regulatory approval, and your product’s success. The stakes are too high when someone’s health is on the line.
Patients count on your app or device to provide them with clear instructions, accurate warnings, and measurements. If a nurse reads the wrong dosage because the units weren’t localized (e.g.m mg instead of µg), that’s not a small slip. That’s a serious risk.
Regulators notice this, too. Your software has to comply with local laws, use the right terminology, and meet their data standards.
❗ Dangers of poor healthcare localization
When Denmark adopted the Epic EHR system across its Capital Region and Zealand Region hospitals, the software’s English-to-Danish translation fell short in critical ways.
Clinicians saw the label “correct” where they expected “right” (i.e., denoting right side of the body). That ambiguity could have led to serious clinical errors.
The fallout was significant. Workflows didn’t make sense, and many clinicians lost confidence in the system. It got so serious that over 600 doctors signed a petition, warning about patient safety risks and demanding major changes. Internal audits flagged serious risks. The organization had to pour millions into post-launch fixes.
Key elements to localize in medical software
When localizing medical software, the stakes are high. Every detail matters. You need to think like a local clinician, a regulator, and a patient, and take into account each party’s needs. Here’s where to focus your attention.
1. User interface and terminology
Every button, label, and menu item needs to make sense to local users. But even within the same language, there can be nuances. Let’s take UK and U.S. English for example.
- UK patient: “I’m going to the doctor’s surgery.” = “I’m going to the doctor’s office”
- U.S. patient: “I’m going to surgery.” = “I’m going to undergo an operation.”
That’s why local context matters, especially in software localization.
2. Measurement units
Units matter a lot. Whether it’s mg/dL or mmol/L, pounds or kilograms, Fahrenheit or Celsius, they all need to be adapted and double-checked for each market. Miss just one, and you could end up with a clinical error or a wrong diagnosis.
3. Date, time, and number formats
Healthcare data is packed with details. Think dates, dosage times, lab results. And the way those are written isn’t the same everywhere. One country might use DD/MM/YYYY, another MM/DD/YYYY. Some use 24-hour clocks, others don’t. Even decimal points and commas switch places.
If that isn’t handled carefully, records can get misread. And in healthcare, that can mean serious delays
4. Clinical workflows and local standards
Many workflows are embedded in the software. Think referral processes, billing logic, or diagnostic coding. Everything needs to match how healthcare actually works in each country. The way care is delivered isn’t the same everywhere, and your software has to reflect that.
This is why in order to localize workflows effectively, you need to involve local medical professionals early in the process for workflow validation.
🏥 Building a localized product with end users in mind
As you localize your medical software, you’ll need to run a clinical workflow mapping session with target-market users. Take a core process in your software. It can be patient referral, prescription approval, insurance claim submission, or something else. Then, walk through it step by step with local doctors, nurses, or admin staff.
Some of the questions you need to ask:
– Is this how it’s done in your hospital or clinic?
– What’s missing or out of order?
– Would any part of this require different documentation or approval here?
Once you collect insights, it’s time to compare your product’s built-in workflow logic against what they describe. You’ll often uncover invisible assumptions baked into your code. For example, the default workflow might imply it’s necessary to issue an insurance authorization before treatment, or to route referrals through specialists who don’t exist in that system.
If you skip this, your software may be linguistically correct but clinically unusable. Product localization cannot be avoided here.
5. Taking care of regulations
Legal content such as consent forms, privacy policies, and data collection notices, has to follow the rules of each country. That means GDPR in Europe, HIPAA in the U.S., or other local medical device laws elsewhere. These are mandatory. Incorrect wording can lead to high fines or even block market entry.
Challenges in medical software localization
Localizing medical software is tough because there’s no margin for error. Everything has to be precise. And we mean everything from language and clinical terms, to the legal content. One small slip can cause confusion or put patients at risk.
1. Regulations vary more than expected
Every country has its own rules for things like privacy, data handling, and clinical records. A consent form that’s fine in the U.S. might not pass in Europe under GDPR. Miss one detail, and you could end up redoing paperwork, delaying your launch, or dealing with unexpected fines.
2. Translating clinical terms is tricky
Just because the translation is technically correct doesn’t mean it’s right for real-world use. Clinicians rely on familiar terms, shorthand, and local language. If your software uses wording they wouldn’t say (or don’t immediately recognize), it can slow them down or cause hesitation.
3. Built-in workflows might not fit local needs
Things like referral steps, billing, or treatment approvals are often built around how healthcare works in your own country. But in another market, those steps might look completely different. Or maybe happen in a different order. If the software doesn’t reflect how care is actually delivered, users won’t adopt it.
💡 Pro tip
It’s unreasonable to expect them to change the way they work. Software has to adapt to their real needs, not the other way around. You’ll likely need to adjust the product itself to reflect:
– Different approval paths (e.g., a referral must go through a generalist before a specialist in some systems)Alternative billing structures (private vs. nationalized healthcare)
– Required data inputs (like national health ID numbers or region-specific codes)
– Varying legal or documentation requirement
So, what does that mean for your product? It means you’ll need to modify forms, reorder steps, toggle features on or off per region, or make certain workflows configurable.
4. Accuracy matters, at all levels
There’s no wiggle room in localizing healthcare apps. A mislabeled dosage, a wrongly formatted date, or a confusing alert can have serious consequences. Here, localization mistakes can impact patient safety or trigger a regulator’s attention.
5. A lot of people need to be included
Localization pulls in people from across the company. Developers, translators, clinicians, compliance experts… Aligning everyone on what needs to change (and why) takes time, clarity, and strong coordination. It’s easy for things to fall through the cracks without a clear owner or process.
💡Tools you use for localization can make a huge difference
Using an all-in-one platform like Lokalise can streamline even the most complex medical software localization projects. It brings developers, translators, reviewers, and compliance teams into a single workspace. This is how everyone stays aligned, and nothing slips through the cracks.
Best practices for localizing medical software
Getting medical translation and localization right requires structure, clinical insight, and a team that’s aligned from day one. Here’s how to get it right.
1. Involve local medical professionals early
Clinicians in your target market can catch localization issues such as inaccurate terminology, flag incorrect workflows, and help you avoid assumptions that don’t translate. Make sure to bring them in during planning and validation.
2. Use region-specific style guides and term bases
Medical language is precise. Build terminology databases and style guides for each region you’re targeting. It keeps translations consistent and helps avoid confusion. Both are very important with sensitive content.
3. Make workflows configurable by region
Hard-coding clinical logic or billing steps can lead to problems later. Build flexibility into your software so workflows, fields, or alerts can be adapted per market without a full rebuild.
🔄 Discover continuous localization
Are you treating localization as an afterthought? You should really stop doing that. There is a way to implement localization inside your product development cycles so that your software is always ready to be launched in a new market. Read more about continuous localization and its benefits.
4. Centralize your localization process
Use a localization platform like Lokalise to manage content, versions, and collaboration in one place. This keeps translators, developers, and reviewers in sync, especially when you work across multiple languages and time zones.
5. Test with real users (not just QA)
Before launch, run usability tests with clinicians or staff who actually work in your target region. This will surface practical issues you’d never catch in a technical QA check. It can be anything from confusing date formats to unexpected interpretations of alerts. This is not a “nice-to-have” step in medical software localization.
Regulatory bodies to consider by region
Before launching medical software in a new market, you’ll need to meet the standards set by local regulatory authorities. These organizations review everything from clinical accuracy to data privacy and software classification.
| Region | Regulatory body | Focus area |
| United States | Food and Drug Administration (FDA) | Medical device classification, software validation, labeling |
| European Union | European Medicines Agency (EMA) and notified bodies | CE marking, MDR compliance, clinical evaluation |
| Canada | Health Canada | Device licensing, bilingual labeling, safety documentation |
| Japan | Pharmaceuticals and Medical Devices Agency (PMDA) | Software as a medical device (SaMD) review, QMS, translations |
| Australia | Therapeutic Goods Administration (TGA) | Regulatory approval, post-market monitoring, documentation |
| Brazil | Brazilian Health Regulatory Agency (locally known as AVISA) | Registration, clinical data, local testing requirements |
| China | National Medical Products Administration (NMPA) | Local testing, technical documentation, Mandarin interface |
🧠 Did you know?
If you’re launching medical software in China, the NMPA requires everything to be in Mandarin. That includes the interface, user manuals, warning messages, and all supporting documents. No exceptions.
This isn’t optional. It’s a regulatory requirement that helps clinicians and patients safely use the product. Without Mandarin localization, your software won’t pass NMPA review or be approved for sale in the Chinese market.
Medical software localization: 3 real-life examples
It’s great to learn about medical software localization in theory, but what are the real-world examples of it? Discover three success stories and key lessons from each.
How Withings achieved 90% faster feature rollout through smart localization
Withings is a global health tech company known for its connected devices like smart scales, blood pressure monitors, and the Health Mate app. Their products are used in over 190 countries and support 11 languages. But how did they get there?
When Withings wanted to release new features faster across 11 languages, they ditched manual spreadsheets and switched to Lokalise linked directly with Figma.
That single change cut their localization prep time from ten hours to just one. It also let designers, translators, and developers work together in context. No more lost strings, mismatched layouts, or QA chaos.
As a result, translation errors dropped, consistency improved, and their HIPAA‑certified app hit markets dramatically faster. We’re talking about a 90% gain in rollout speed.
🗒️ Key lessons from Withings
1. Localize early, and in the design phase
Link your design tool (like Figma) directly to your localization system. Translators can see UI context right away, catch issues like text overflow, and improve quality before development starts.
2. Bring everyone together in one workflow
With designers, developers, translators, and reviewers in the same system, handoff delays disappear and everyone understands the full context of each string.
3. Automation helps you scale and stay compliant
Fewer manual tasks mean less chance for mistakes. Automation ensures translation consistency, built-in quality checks, and much faster release cadences.
How Smartpatient managed to add 7 new languages per year
Smartpatient is the company behind MyTherapy, a medication reminder and health tracking app used by millions of patients around the world.
As demand for the app grew globally, they faced a major challenge. How will they scale localization across dozens of languages, without slowing down development or compromising clinical accuracy?
Starting with just four languages, they expanded to 31 languages in four years. And they did it with a small, agile team and a well-integrated tech stack. Such a powerful example of mobile app localization done right.
🗒️ Key lessons from Smartpatient
1. Automate the end-to-end translation workflow
You need a centralized localization platform. Smartpatient connected string uploads, Slack notifications, and translation downloads through Lokalise’s API and SDKs. This automation made adding 27 new languages much easier.
2. Use context-rich tools like screenshots and glossaries
Smartpatient leverages features like in-context screenshots and translation memory to ensure accuracy and consistency. Translators see exactly how text fits into the UI.
3. Be smart with resources
Despite dealing with over 30 languages, their localization process runs smoothly with just a few people. Lokalise’s intuitive UI and integrations (Slack, API, SDKs) let a compact team manage complex, multilingual workflows
How Doxy.me went from one to 100 languages in a few months
Doxy.me is a telemedicine tool that offers free, secure video visits for clinicians and patients worldwide, originally focused on prenatal care. In the early days, they managed localization with spreadsheets, emails, and manual copy-paste. This was rather slow.
When the pandemic hit, demand exploded. Users jumped from around 65,000 providers to over 1 million in more than 150 countries.
To scale quickly and ensure both patients and doctors could use the platform in their native language, they started using Lokalise.
Within a few months, Doxy.me grew from one supported language to 100+ for patients and 20+ for doctors, all powered by end-to-end automation via GitLab and Intercom integration.
🗒️ Key lessons from Doxy.me
1. Automate early to scale fast
When demand surged, Doxy.me moved away from manual workflows and used a translation software with integrations with GitLab and Intercom to automate localization. This let them scale from 1 to 100+ languages without slowing down releases.
2. Translate for all users (not just clinicians)
They localized the experience for both doctors and patients. They were aware that trust and usability depend on everyone being able to navigate the platform in their own language.
3. Support matters, too
With the right tool support, their customer support team could chat with users in real time, in any language. This helped build trust globally and reduce frustration in high-stress healthcare moments.
Want to learn more about healthcare localization?
Medical software localization is about precision. Every label, unit, and workflow has to fit the local context without introducing risk or confusion.
It takes time, and it takes input from the right people. But when done properly, it means your product works as intended for patients, for clinicians, and for regulators.
No extra explanation needed. No second-guessing. Just software that’s clear, trusted, and ready to be used.
If you want to learn more about healthcare localization, please check out our customer stories here.Wondering if Lokalise would be a good fit for you? Try it out for yourself for 14 days. It’s completely risk-free, we won’t ask for credit card details from you.
