Número da Revisão
Rev.01
Data de Expiração
26/09/2027
Descrição
Scope: Scope: Design and development, manufacturing, sales and technical service of respiratory mechanics monitors and accessories
Norma
ISO 13485:2016 Brazil: RDC ANVISA no. 665/2022 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