Journal

Biomedical instrumentation & technology
ISSN: 0899-8205
Titre abrégé: Biomed Instrum Technol
Pays: United States
ID NLM: 8905560

Informations de publication

Date de publication:
Historique:
entrez: 23 5 2020
pubmed: 23 5 2020
medline: 28 7 2020
Statut: ppublish

Résumé

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 the suggested practices described in this article to address regulatory requirements.

Identifiants

pubmed: 32442013
doi: 10.2345/0899-8205-54.3.178
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

178-188

Auteurs

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Classifications MeSH