Número da Revisão
Rev.02
Data de Expiração
25/09/2027
Descrição
Scope: "Design and development, manufacture and service of respiratory mechanics monitors and non-sterile accessories.”
Norma
ISO 13485:2016 Canada: Medical Devices Regulations – Part 1- SOR 98/282 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