title: The quality planning conundrum.
abstract: Quality planning activity is an important element of a documented quality system. As a result, European and United States quality system requirements include the need to document this activity. However, many medical device companies encounter difficulties in trying to understand exactly how to interpret quality planning requirements. This article discusses these requirements and various approaches to conformity.
authors.affiliation: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it www.donawa.com
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D017749:Total Quality Management / Q000592:standards*; D014481:United States