Data and Its Impact on Medical Technology Companies Doing Business in the EU

Today's medical technology industry is being transformed by data—clinical data, vigilance data, real world data and personal data. As such, there is a growing need for fully integrated data generation, collection and analysis as part of the development and marketing of medical technology. As a result, companies seeking to launch new technologies in the EU or expand the labeling of their EU-marketed products need to consider the regulatory and economic burden of complying with new, heightened data submission requirements.

Topics

This webinar is designed to provide guidance on the following issues:

• Identifying the clinical data needed to comply with European Medical Devices Regulations as compared to FDA requirements.
• Generating post-marketing data to support the clinical and economic value proposition for medical technologies.
• Addressing data security and privacy concerns, with a focus on digital health.