Recent guidance from regulators emphasizes bioassays and potency assurance strategies, underscoring the robustness of these ...

The director of CDI/utilization review at Avera Health reviews two key areas needed to shore up clinical validation denials. Denials management has become a major area of concentration for revenue ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...