Número da Revisão
Rev.01
Data de Expiração
25/12/2027
Descrição
Scope: Design, development, manufacturing, sales, distribution, installation and technical assistance of dental office, clinical chairs and tables, reflectors and dental X ray. Distribution of handpieces of high and low rotation, dental electrical, electronics and pneumatic motors, curing light, dental ultrasonic and compressors.
Norma
ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) – Full Quality Assurance System Schedule 3, Part 4 – Production Quality Assurance Procedures Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) 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 21 CFR Part 821 – Device Tracking
Status
Ativo