Our medical device clients face three main challenges in the preclinical phase: time, cost, and interdependency of documents.
The research, development, and validation of a medical device is a phase that can take years and significant budgets to complete. We can help speed up parts of this process, facilitating research and collaboration through rapid translation and cultural advice. We can also put our custom AI to work to streamline translations required for regulatory approval and reduce associated costs.
In accordance with Good Clinical Practice (GCP), many of the documents created in the preclinical phase will be living documents, requiring continuous updates throughout the lifecycle of the device. The interdependency of these documents means that a change to one often necessitates changes across multiple others. If you’re translating into the 25 languages of the EU, for instance, this can mean a lot of ongoing, time-sensitive rework. At Conversis, we maintain careful version control and have developed custom AI tools to isolate, manage, and translate content updates, ensuring all language versions of all documents remain up to date and submissible for regulatory purposes internationally.
