On 30 September, I had the pleasure of presenting at a Tremédica webinar on “Excellence in Medical Device Translations. Regulatory Compliance and Beyond. Meeting Compliance Without Fear.”
During the session, I covered several key areas:
The importance of consistent terminology with MedDRA, EDQM, IVDRF, GMDN, and EMDN. For a related perspective on terminology management, read Who Really Owns Your Translation Memory (TM) and Glossary?
ISO standards (17100, 9001, 13485) and their requirements for language services. For more information, explore our article ISO in Life Sciences Translations: A Complete Framework for Medical Device Manufacturers.
MDR and IVDR language requirements, and how they impact medical and regulatory translations.
The role of local legislation and national guidance in ensuring compliance.
Documentation that meets ISO, MDR/IVDR, and local requirements is not just a regulatory necessity — it is central to audit readiness and patient safety.
If you couldn’t attend the live session or would like to revisit the discussion, please email info@nntranslations.com to request the full webinar recording.
You can also explore our Medical Device and IVD Resources → for additional guidance on MDR/IVDR requirements, terminology and translation quality. Explore more educational sessions on medical device translation and regulatory compliance in our Medical Device Webinars & Workshops →
I would love to hear your feedback:
Which parts felt most relevant to your organization?
Do terminology, ISO, or language requirements create challenges in your workflows?
What are your most common concerns in terms of translation and localisation?
Your insights are invaluable, and they will help me shape future sessions for the MedTech and IVD community.
