title: Complying with US and European change control requirements, Part I.
abstract: The successful operation of medical device companies is significantly affected by their ability to continually improve their products and operations. Also, from time to time, problems need to be resolved. These activities are often associated with changes that must be made and effectively managed. Part I of this two-part article will discuss United States and European quality system requirements for controlling changes to products, processes and documentation. Part II will discuss change control procedures and regulatory notification issues.
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 / Q000331:legislation & jurisprudence / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006801:Humans; D011786:Quality Control; D014481:United States