Open Hand

Overview

The Open Hand project offers a unique approach to the regulatory review process in which IVD manufacturers engage with an interactive review session and share learnings between sponsors to advance the understanding of fit-for-purpose RWD to generate RWE.

COMING SOON

New Release on Facilitating the Use of RWE

Be on the look out for our newest publication! The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency 

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Open Hand Working Group

Active Open Hand Working Group members represent the following IVD stakeholders:

  • Becton Dickinson
  • Roche
  • Siemens-Healthineers

Explore ClinDx Resources

Predetermined Change Control Plans for AI and ML-enabled Medical Devices

Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs)

SRS Landscape Analysis Report