Número da Revisão
Rev.02
Data de Expiração
12/03/2028
Descrição
Scope: "The design, development, manufacture, and service of monitoring and diagnostic medical devices"
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations (SOR/98-282) Part 1 - General USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation.
Status
Ativo