title: Complying with US nonconforming product requirements.
abstract: Medical device companies are often surprised to learn that their procedures for controlling nonconforming products meet European requirements, but do not meet United States requirements. This article discusses why this occurs and how to avoid this discrepancy.
authors.affiliation: Donawa Consulting, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration