Número da Revisão
Rev.02
Data de Expiração
11/06/2027
Descrição
Scope: "Manufacture, import, export, distribution, design, installation, technical assistance, training and rental of electromedical and medical-hospital devices in the neurosurgery and general surgery areas, including their consumables (sterile and non-sterile) and the development of software related to the healthcare area".
Norma
ISO 13485:2016 Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009
Status
Ativo