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.
- ISO standards (17100, 9001, 13485) and their requirements for language services.
- MDR and IVDR language requirements, and how they impact 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 weren’t able to attend live, or if you’d like to revisit the discussion, please, contact me to send you the full recording at info@nntranslations.com
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.