Key Takeaways from Our BIVDA Webinar
In December 2025 we had the opportunity to deliver a webinar for members of the British In Vitro Diagnostics Association (BIVDA), joined by non-members from across the medical device and life sciences sector. The session focused on a practical and often underestimated topic: how medical device manufacturers can work effectively with translators and language service providers (LSPs).
The audience included medical device manufacturers, regulatory affairs professionals, consultants, notified bodies, and other stakeholders involved in multilingual regulatory documentation. Rather than presenting services, the aim of the webinar was to share practical insights, common pitfalls, and best practices drawn from real-world experience.
Below are the key takeaways from the session.
Translation Is Part of the Quality and Compliance Chain
One of the main messages of the webinar was that translation should not be seen as a purely linguistic or final administrative step. Although it often comes at the end of the documentation process, translation has a direct impact on:
- regulatory compliance
- clarity and consistency of documentation
- patient and user safety
High-quality translation means preserving the intent and precision of the original regulatory content. It should not simplify, reinterpret, or alter meaning. For this reason, translation needs to align with the same regulatory and quality frameworks medical device manufacturers already work with, including MDR, IVDR, international labelling standards, and national requirements.
Common Challenges When Working with Translators and LSPs
The webinar highlighted several recurring challenges that can arise during the translation process, such as:
- unclear or incomplete source text
- missing references or glossaries
- vague briefs or missing style guidance
- short text fragments provided without context
- unrealistic timelines
- too many reviewers and conflicting feedback
An important takeaway was that most of these challenges are solvable. With early planning, clear instructions, and open collaboration between manufacturers, LSPs, and translators, many risks can be prevented before they affect quality or timelines.
How to Work More Effectively with Translators
Practical guidance shared during the webinar included:
- always providing context, purpose, and target audience information
- sharing terminology, references, and instructions early
- keeping communication channels open and responding to queries promptly
- encouraging translator feedback, as linguists often identify unclear or inconsistent source text
- respecting quality steps, especially translation followed by revision, which is mandatory under ISO 17100
A key point was that even for patient-facing content, revision should never be skipped, as it directly supports safety and compliance.
Working with Freelance Translators vs. LSPs
A common question discussed was whether companies should work directly with freelance translators or with an LSP.
While it is possible to work directly with translators, doing so requires strong internal capabilities in vendor management, quality assurance, terminology control, and risk management, especially for complex multilingual projects. Verifying expertise, ensuring consistency across languages, and managing updates can be challenging without established processes.
Specialized life sciences LSPs typically offer:
- pre-vetted and tested linguists
- documented and repeatable workflows
- terminology and version control
- accountability when issues arise
- ISO-aligned quality frameworks
The key message was not that one model fits all, but that risk, complexity, and internal resources should guide the decision.
Audit Expectations and Translation Evidence
The webinar also addressed how translation is viewed during inspections. In most cases, notified bodies focus less on individual wording and more on whether translation is managed as a controlled process. This can include:
- documented translation and revision workflows
- evidence of qualified linguists
- traceability between source and target documents
- terminology and version control
- procedures for handling updates and corrections
This reinforces the importance of treating translation as an integrated part of the quality management system.
Final Thoughts
The webinar concluded with a simple but important message:
Working effectively with translators and LSPs is about collaboration, clarity, and process.
When medical device manufacturers LSPs, and translators work openly together, with clear briefing, timely communication, and structured quality steps, translation becomes a reliable support function helping ensure compliance, reduce rework, and maintain consistency across markets. In that context, the LSP is not just a supplier, but a proactive partner that can help you navigate your language and documentation requirements.
If you’re a medical device manufacturer reviewing or improving how translation fits into your MDR/IVDR processes, we’d be happy to discuss your current setup, challenges, or upcoming projects.
Feel free to get in touch to explore how your translation workflows can better support compliance, consistency, and patient safety.