title: Complying with US and European complaint handling requirements.
abstract: The importance of customer complaints for providing valuable information on the use of medical devices is clearly reflected in United States (US) and European quality system requirements for handling complaints. However, there are significant differences in US and European complaint handling requirements. This article will discuss those differences and methods for ensuring compliance.
authors.affiliation: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D003257:Consumer Product Safety; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D005060:Europe; D006801:Humans; D007255:Information Services; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration