Número da Revisão
Rev.03
Data de Expiração
19/03/2027
Descrição
Scope: ‘’Design, development, manufacturing, after-sales of products for cardiopulmonary use. Import, commercialization and after-sales of products for cardiopulmonary use and implantable neuromodulation devices and servicing of extracorporeal blood treatment equipments 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 21 CFR Part 821 - Device Tracking
Status
Ativo