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.
Discover more educational sessions for medical device and IVD manufacturers on our Medical Device Webinars & Workshops → page.
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. This is particularly important for medical and regulatory translation, where accuracy, traceability and consistency support regulatory compliance. 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.
Maintaining access to approved terminology and translation memories is equally important. Read our Who Really Owns Your Translation Memory (TM) and Glossary? article.
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
For a closer look at how these quality steps are organised, explore our Medical Device Translation Workflow: Quality, Compliance & Long-Term Value article.
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 medical device 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.
Learn how documented translation workflows and quality management systems work together in our ISO in Life Sciences Translations article.
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.
For additional practical guidance on translation workflows, quality management and regulatory documentation, explore our Medical Device and IVD Resources →
