The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the process, teams generate more robust evidence and stronger submissions, which often means a shorter approval process.
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
Companies within the life sciences industry should rethink how they manage their data and documents.
Robotic process automation (RPA) is reducing time spent on repetitive tasks in regulatory affairs and regulatory operations. The next step is artificial intelligence-enhanced RPA, which has the potential to automate more unstructured tasks.
Entering the Japanese device market requires an excellent regulatory team.