Número da Revisão
Rev.04
Data de Expiração
06/10/2025
Descrição
Scope: Design, Development and Production of medical devices for endoscopy, gastrostomy and urology
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