Whitepaper

Raising the standard for device evidence

Medical device companies face growing pressure from regulators, payers, and providers to demonstrate safety, performance, and value with greater precision and speed. Yet, the data sources historically relied upon—claims, chargemaster, and registries—were designed for billing or narrow reporting, not for lifecycle-wide insight. They lack device-level detail, clinical context, and timeliness at a moment when high-quality real-world data is increasingly required for regulatory submissions, comparative studies, and market access.

Truveta provides regulatory-grade, research-ready device data. With daily updated EHR data from a collective of US health systems, device identity mapped to unique device identifiers (UDIs), and linked notes, images, and cost data, Truveta enables a complete and transparent view of device use across diverse populations and care settings. This foundation supports regulatory submissions, clinical development, trial design, safety monitoring, and demonstration of clinical and economic value.

Read this whitepaper to learn:

  • Why legacy RWD sources can no longer meet regulatory and market expectations for device evidence.
  • How Truveta achieves device-level precision—mapping 45M+ device uses to UDIs with full provenance.
  • The breadth of clinical, operational, and financial data available to study device use across real-world practice.
  • Examples of how device companies are using Truveta Data to inform design, accelerate trials, demonstrate value, and expand adoption.

Read the whitepaper now