Real-world evidence in medical device regulation: From data to decision-ready evidence
This edition of Evidence Insights, supported by Premier Applied Sciences, explores how real-world data (RWD) and real-world evidence (RWE) are being used to support medical device evaluation amid evolving regulatory expectations. Drawing on Premier's expertise and strategic partnerships, the collection examines what makes RWE fit-for-purpose, how it complements traditional clinical trials, and where regulatory-grade RWE can add the most value for device manufacturers.
Infographic
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Infographic: Real-world evidence for medical devices – Regulatory-grade data in practice As regulatory expectations for medical device evidence evolve, high-quality longitudinal RWD are helping generate scalable, decision-grade RWE beyond traditional trials. View this infographic to learn more.
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Expert interview
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Video: The use of RWD and RWE in medical device evaluation with Ariann Stone & Myla Maloney, Premier Applied Sciences Laura Dormer, Editor of The Evidence Base, speaks with Ariann Stone and Myla Maloney, Premier Applied Sciences, about the role of large, fit-for-purpose healthcare datasets in supporting the regulatory needs for medical devices. |
Partner feature
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Partner feature: The use of real-world data and real-world evidence in medical device evaluation Read more insights from Ariann Stone and Myla Maloney on how fit-for-purpose healthcare datasets can help medical device manufacturers address key challenges, expand opportunities, and support broader, more consistent adoption of RWE. |
In association with
Sponsorship for this Evidence Insights was provided by Premier Applied Sciences.