Implementing a Team-Based Approach to Medical Device and Radiological Product Evaluation and Quality.

Autor: Maisel, William, Shuren, Jeff
Předmět:
Zdroj: Biomedical Market Newsletter; 6/1/2019, p16-19, 4p
Abstrakt: The article provides information on operational transformation and the approach to work in U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). CDRH has announced change to a more team-based approach to premarket review and compliance which improves its focus on safety in the whole lifecycle of medical devices.
Databáze: Complementary Index