Insights Hub
Educational sessions on Linguistic Validation, medical device translation, MDR/IVDR considerations and regulatory guidance.
Explore our webinars, workshops and practical video resources covering medical device and IVD content, translation workflows, regulatory requirements, terminology, quality and effective stakeholder collaboration.
These resources bring together practical experience and specialist perspectives to help medical device and IVD teams manage multilingual and regulated content more effectively.
This webinar was specifically designed and delivered for the members of the British In Vitro Diagnostic Association (BIVDA), in response to their request for practical guidance on working with translation partners. It explores how to select an LSP, an individual translator or a team of translators, the less visible challenges of medical device translation, and practical considerations for establishing effective collaboration and quality workflows.
Explore selected highlights from the webinar below.
Medical device translations often involve hidden challenges such as unclear source text, missing references or glossaries, limited context, vague briefs, unrealistic timelines, and conflicting reviewer feedback, all of which can impact quality and compliance.
With over 700,000 translators worldwide, verifying expertise, quality, and reliability is difficult. Many companies lack vendor management and QA structures, while online platforms often offer no ISO workflows, terminology control, accountability, or risk management.
Working effectively with translators means sharing purpose and context, providing clear briefs and terminology early, keeping communication open, and respecting essential quality steps. Timely client feedback directly impacts quality and delivery.
Effective collaboration with LSPs relies on life-sciences expertise, ISO-aligned workflows, clear roles and communication, strong terminology and version control, a transparent AI/MT policy, and full process and pricing transparency.
The 2026 Strategy & Planning for Medical Device Manufacturers online workshop focused on real-world operational considerations surrounding multilingual medical device documentation, regulatory readiness and long-term scalability.
It explored practical approaches to project preparation, IFU language requirements, terminology and translation-memory ownership, distributor involvement and other considerations affecting multilingual medical device content.
Explore selected highlights from the workshop below.
Why unclear or incomplete briefs are one of the most common causes of delays, rework, and quality issues and what information should be included from the outset to ensure smoother workflows.
An in-depth look at the disconnect between regulatory acceptance of English-only IFUs and the practical challenges encountered during actual market sales, device deployment and distributor use.
Who should own translation memories and terminology assets and how ownership impacts consistency, compliance, scalability, and long-term cost control.
How to involve distributors in the translation process without losing control, consistency, or regulatory alignment.
This webinar was delivered in collaboration with Tremédica and explores key considerations surrounding medical device translation within the European regulatory environment.
Selected excerpts cover NN Translations, applicable quality standards, the regulatory landscape, compliance and safety, and the management of end-to-end medical device translation workflows.
Explore selected highlights from the webinar below.
We are a specialized life sciences translation and business outcomes partner supporting medical device manufacturers with precise, regulator-ready translations across global markets.
Our workflows are built around ISO-certified processes, experienced medical linguists, and multi-step quality controls to ensure accuracy, consistency, and traceability.
We help you move confidently through MDR, IVDR, and international regulatory requirements by aligning language, documentation, and terminology with current expectations.
Every translation is handled with patient safety, risk mitigation, and regulatory compliance in mind because in medical devices, words matter.
We deliver complete medical device translation solutions from instructions for use and labels to technical files managed seamlessly from start to finish.
Talk to us about your clinical research, COA/eCOA or medical device requirements.