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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorRodríguez, José
dc.contributor.authorFigueroa, Yazmín
dc.date.accessioned2022-07-26T15:38:44Z
dc.date.available2022-07-26T15:38:44Z
dc.date.issued2010
dc.identifier.citationFigueroa, Y. & Rodríguez, J. (2010). Comparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485. Politechne, 15(1), 67-76.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1670
dc.descriptionVolumen 15, Número 1, Abril 2010en_US
dc.description.abstractThis paper compares the quality system requirements of the Code of Federal Regulations 21 CFR part 820 with the quality system requirements of the International Standard ISO 13485. The medical devices industry that distributes product in the domestic (United States of America) market and in the international (European countries) market shall comply with the regulations (CFR 820 and ISO 13485:2003) and the harmonization of both requirements in one quality system is the ideal process to avoid the missing of any of the requirements. This comparison will help to understand the international and the domestic quality system requirements and the quality system maintenance. A guideline was developed for a sterile medical devices industry to implement a single quality system which includes international and domestic quality system requirements without the missing of any of the requirements.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofRevista Politechne;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Subject headings--Unassigneden_US
dc.subject.lcshPolytechnic University of Puerto Rico--Faculty--Researchen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Undergraduates--Researchen_US
dc.titleComparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485en_US
dc.typeArticleen_US
dc.rights.holderEsta Junta Editorial y la Universidad Politécnica de Puerto Rico hacen constar y reconoce que los autores de los artículos, obras literarias y artísticas publicadas en esta Revista Politechnê, se reservan enteramente los derechos de autor y de publicación de los mismos para los efectos de cualquier eventualidad literaria, publicitaria o de cualquier índole.en_US


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Das Dokument erscheint in:

  • Revista Politechnê
    Revista multidisciplinaria de la Universidad Politécnica de Puerto Rico (Vol. 1 | Núm. 1 | Junio 1991 - Vol. 19 | Enero 2018)

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