Real-World Evidence

Medical Device Registry

Structured long-term data collection for devices requiring ongoing surveillance or longitudinal outcome assessment.

HomeClinical InvestigationMedical Device Registry

A registry can provide structured longitudinal information on device utilization and clinical outcomes, complementing prospective and retrospective clinical investigations.

Suitable For
  • Implantable devices
  • Long-term safety surveillance
  • Long-term performance monitoring
  • Rare adverse events
  • Reinterventions
  • Device durability
  • Routine clinical use

Can a Registry Be Used for Ongoing Device Surveillance?

Yes. A device registry can be an appropriate methodology when designed to address relevant long-term safety, performance or clinical-benefit questions across a device's expected lifetime.

HIPAA Compliant
ICH-GCP Compliant
FDA 21 CFR Part 11
ISO 9001
ISO 14155
ISO 27001 Certified
EU MDR 2017/745
EU IVDR 2017/746
US FDA Requirements
ISO 20916

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