A practical approach to multilingual updates for medical devices 

Managing multilingual content, whether it’s IFUs, packaging, or regulatory documentation. doesn’t have to be overwhelming. Still, many medical device companies face last-minute pressure before audits, product launches, or regulatory submissions. 

The advantage? With the right framework, updates can be completed quickly, cost-effectively, and in full compliance. Here’s how to make multilingual updates an integrated and predictable step in your product lifecycle. 

1. Integrate updates into your product lifecycle 

Stress often arises when translations are handled as a separate activity, only initiated once every other update is finalized. This approach risks delays and outdated documentation. 

Instead, embed translation into your Quality Management System (QMS) so updates are triggered automatically when source documents change. At Novalins, our ISO-certified workflows are built to align with medical device QMS standards, ensuring translations are managed with the same traceability and rigor as core documentation. 

2. Optimize and maintain your translation memory 

Approved translations are valuable resources. A well-managed translation memory (TM) allows teams to reuse validated content, lowering costs, improving consistency, and shortening delivery times. 

Consistency is also gained by partnering with the same translation teams for updates. They already know your products, regulatory context, and style preferences. At Novalins, we combine these partnerships with advanced TMS technology that compares new content with past translations, so you don’t pay twice for repeated text. 

3. Establish clear version control 

For stress-free updates, always send the final, approved source version, and ensure it’s clearly marked. 

• Use consistent file naming conventions 

• Add version dates to filenames 

• Provide a simple change log for visibility 

It’s equally important to indicate which project or product the update relates to. This allows your translation partner to quickly locate past work, assign the right team, and prepare accurate quotes without delays. Clear connections between old and new projects reduce risks and keep timelines on track. 

This also prevents the costly mistake of translating outdated text, which can lead to rework or compliance issues. 

4. Anticipate regulatory requirements 

Updates aren’t only about text. Regulatory shifts, like terminology changes, layout rules, or new labeling standards, may affect multiple languages simultaneously. 

With Novalins’ compliance check service, multilingual content is reviewed against MDR and local regulations, helping you identify issues early and avoid submission delays. 

5. Use AI responsibly with expert oversight 

AI can support partial updates by reducing costs and turnaround times, but it must be applied carefully. In medical devices, accuracy and compliance are non-negotiable, so AI output must always be reviewed by subject-matter experts. 

Our AI workflows are designed specifically for medical device translations, combining secure tools that protect your data with expert post-editing to ensure quality and compliance. 

6. Plan your reviews in advance 

Even a streamlined translation process can stall if review steps are overlooked. 

• Assign in-country reviewers familiar with both product and regulations 

• Share timelines early to integrate reviews into the overall schedule 

Quick checklist before sending files 

✅ Confirm final source file and version 
✅ Identify updated vs. unchanged sections 
✅ Share regulatory context and target countries 
✅ Provide approved translations and glossaries 
✅ Align on AI-assisted vs. human-only approach 
✅ Define review steps, reviewers, and deadlines 

From last-minute tasks to structured processes 

By approaching multilingual updates as a repeatable, well-planned process, you minimize stress, reduce costs, and stay compliant with MDR and local requirements. 

At Novalins, we support medical device companies with ISO-certified workflows, AI-enhanced solutions, and regulatory compliance checks, ensuring updates are managed seamlessly. 

Interested in our free MDR compliance checklist tailored by country? Reach out, it’s a practical first step toward making your next update stress-free.