Your guide to stress-free multilingual updates for medical devices 

Updating your multilingual content, whether it’s IFUs, packaging, or other regulatory documents, doesn’t have to be a source of stress. Yet for many medical device companies, even experienced teams find themselves in a last-minute scramble before audits, launches, or regulatory submissions. 

The good news? With the right processes in place, updates can be fast, cost-efficient, and fully compliant. Here’s how to make multilingual updates a smooth, predictable part of your product lifecycle. 

1. Treat updates as part of your product lifecycle, not an afterthought 

One of the most common causes of stress is treating translations as an isolated task, triggered only after all other updates are complete. This approach increases the risk of missing deadlines or releasing outdated documents. 

Instead, build translation into your Quality Management System (QMS) workflows so it’s triggered automatically when source documents change. At Novalins, our ISO-certified processes are designed to align with medical device QMS requirements, so translations follow the same level of traceability and control as your core product documentation. 

2. Keep your translation memory clean and updated 

Every approved translation you’ve paid for is an asset. A clean, well-maintained translation memory (TM) allows linguists to reuse existing content, cutting costs, ensuring consistent terminology, and reducing turnaround times. 

Whenever possible, work with the same translation teams for updates. They already know your products, regulatory context, and preferred style. At Novalins, we combine these long-term partnerships with powerful TMS tools that match updated text against past translations, so you never pay twice for the same work. 

3. Make version control crystal clear 

If there’s one rule for stress-free updates, it’s this: only send the final, approved source version for translation, and make sure it’s clearly labeled. 

• Use consistent file naming 

• Include version dates in the filename 

• Keep a simple change log so translators can see what’s new 

It’s equally important to tell your translation partner which project or product the update belongs to. This helps them quickly locate previous translations, match the right translation team, and prepare an accurate quote without delays. The clearer the link between your update and its original project, the faster your vendor can start work and the less risk there is of missing a deadline. 

This avoids the risk of translating outdated text, which can lead to costly rework or even compliance issues. 

4. Flag regulatory changes early 

Content updates are not always just about text changes. Regulatory shifts, such as country-specific terminology, layout adjustments, or new labeling rules, can impact multiple languages at once. 

Novalins’ regulatory compliance check service reviews your multilingual files against MDR and country-specific requirements, so you catch gaps early and avoid delays at submission. 

5. Consider AI-assisted translation for efficiency, but keep expert oversight 

For partial updates, AI can accelerate turnaround times and reduce costs, but it must be applied strategically. In medical devices, accuracy and compliance can’t be compromised, so AI output should always be reviewed by specialist translators. 

Our AI workflows are designed for the medical device sector, using secure tools that protect your data, combined with expert post-editing to ensure quality and regulatory compliance. 

6. Align on a realistic review plan 

Even the fastest translation process can stall if reviews aren’t planned in advance. 

• Assign in-country reviewers who know both the product and the regulatory context. 

• Share timelines early so review cycles are built into your project schedule. 

Checklist: before you send your update for translation 

• ✅ Confirm final source file and version 

• ✅ Identify updated sections vs. unchanged text 

• ✅ Provide regulatory context and target countries 

• ✅ Share past approved translations and glossaries 

• ✅ Align on AI-assisted or human-only approach 

• ✅ Define review process, reviewers, and deadlines 

From reactive to proactive 

When multilingual updates are treated as a planned, repeatable process, not a last-minute task, you reduce stress, control costs, and ensure full compliance with MDR and local regulations. 

At Novalins, we help medical device companies manage updates seamlessly through ISO-certified workflows, AI-assisted efficiency, and regulatory compliance checks.  

If you’d like a copy of our free country-specific MDR compliance checklist, get in touch, it’s the first step towards making your next update truly stress-free.