Número da Revisão
Rev.01
Data de Expiração
30/07/2028
Descrição
Scope: "Design, development, manufacture and service of surgical laser systems, cryotherapy systems, radiofrequency systems, magnetic muscle stimulation systems and light systems for medical and aesthetic use."
Norma
ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations (SOR/98-282) Part 1 – General 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