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

June 18, 2019
Arnold & Porter Webinar

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.

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