Completing regulatory submissions for medical devices is a challenging process, often far less centralized than the equivalent process for pharmaceuticals. We’ve got specialist teams, workflows, and tools in place to tackle those challenges and help you get your device into international markets.
Submissions to regulatory authorities tend to come with extremely tight timelines. We have developed custom workflows and AI efficiency tools to streamline and speed up the translation process. This, combined with our expert linguists, allows us to consistently manage these timelines with ease.
Another major challenge our clients encounter in this phase is the sheer volume of content they need to produce and maintain. The purpose of the submission process is to evidence transparently and holistically the entire development journey of the device to this point. This entails creation and management of a wealth of documentation, much of which is interdependent and must be updated regularly. When multilingual versions are factored in, the whole process can become very resource-intensive. Our clients centralize their multilingual content management with us – trusting us to perform original translations, multilingual updates, and careful version control.
Finally, there’s the varying and complex regulations our clients need to satisfy internationally. The Conversis regulatory team remains up to date with global regulatory shifts, while our in-country linguists keep us, and our clients, on top of local changes. As such, we ensure that submissions consistently meet requirements across all territories.
