title: Avoiding surprises when implementing a single quality system.
abstract: European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quality system.
authors.affiliation: Donawa Consulting, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D011786:Quality Control; D015203:Reproducibility of Results; D012984:Software; D014481:United States