title: Achieving systematic compliance with the Medical Device Directive.
abstract: This article outlines key issues that will aid successful compliance with the requirements of the Medical Device Directive through ISO 9000/EN 46000. A well-constructed quality system that complies with these standards will also act as a good basis for ensuring compliance with many other global regulatory requirements.
authors.affiliation: Amtac Certification Services, Altrincham, UK.
authors.forename: R
authors.initials: R
authors.lastname: Lally
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D004282:Documentation; D004864:Equipment and Supplies / Q000592:standards* / Q000600:supply & distribution; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control