Número da Revisão
Rev.04
Data de Expiração
18/03/2027
Descrição
Scope: Design, development and manufacture of sterile disposable products for cardiopulmonary use. Distribution of products for cardiopulmonary use and implantable neuromodulation devices. Service of extracorporeal blood devices for the area of cardiovascular.
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 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