Complying with US nonconforming product requirements.
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.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
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