Clinical Evaluation Open question

Can translated instructional video text be adjusted for lip sync without affecting evidence transferability?

Anonymous · Published February 09, 2026 · 2 comments
We are preparing to launch our medical device app in a new country and are working with a certified translation agency to translate instructional videos. Our aim is for evidence from a German clinical study to be accepted as transferable. We want to minimize changes to the app content. However, to sync the translated text with the video, some text adjustments are needed for proper lip sync.
  • Is it acceptable to adjust the translated text for lip syncing, or would this compromise the chain of evidence from the original study?
  • Alternatively, do we need to create entirely new videos using the exact translated text from the agency?

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

Anonymous 4 months ago
Can you clarify what role these videos play in the device?
Reply to this comment
Anonymous 4 months ago
These videos are instruction videos, for example, demonstrating how to perform pelvic floor exercises.
Reply to this comment

Discussion

0 Answers

No answers yet. Be the first to reply!
Want to add your answer to this question?
Write an answer under your name by logging in or signing up, or post anonymously.

Still have a question? Ask a question here publicly — for free.

Or talk to one of our consultants — first calls are free. Check out our services and prices.

Looking to automate your regulatory work? Check out our eQMS, Formwork. Built for lean, founder-led companies. There’s a free version too.