Real World Evidence for Class III Devices: A Smarter Path to PMA

Struggling to generate clinical evidence for Class III devices without costly, multi-year trials?

Discover how ProPharma helped an orthopedic device company leverage existing registry data to support a PMA submission, reducing development burden, accelerating timelines, and maintaining regulatory rigor.

For Class III medical devices, clinical evidence requirements can significantly impact timelines, cost, and overall program viability. In this case study, ProPharma demonstrates how a strategic, science-driven approach to Real World Evidence enabled a sponsor to transform existing data into a viable regulatory pathway without compromising quality or compliance.

Whether you are evaluating alternative evidence strategies or navigating complex FDA expectations, this case highlights what is possible when regulatory and clinical expertise are fully integrated.

Download the case study to learn how our team helped:

• Avoid a large, costly prospective clinical trial
• Leverage registry-based Real World Evidence to support a PMA strategy
• Align with FDA on a non-traditional evidence approach through early engagement
• Address data gaps, adverse event classification, and regulatory expectations
• Accelerate time to approval by several years while reducing development risk

Download the case study now and learn how our team of regulatory consultants delivers innovative regulatory strategies that reduce burden and accelerate approval.