Analysis: Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices.
PMID: 32442013 · 2020
T, e, r, e, s, i, t, a, , C, , L, i, e, b, e, l, ;, , T, a, r, a, , D, a, u, g, h, e, r, t, y, ;, , A, l, e, x, a, n, d, r, a, , K, i, r, s, c, h, ;, , S, h, a, r, i, f, a, h, , A, , O, m, a, r, ;, , T, a, r, a, , F, e, u, e, r, s, t, e, i, n
Publicidade
Resumo
This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage
Publicidade
Fonte oficial
Ver no PubMed →Dados provenientes do PubMed / NCBI. Para consultar o texto integral e as informações mais recentes, recorra sempre ao registo oficial.