Atuação

A NCC tem como diferencial a competência e experiência técnica em todas as atividades de avaliação da conformidade, considerando os aspectos da qualidade, da segurança e do desempenho de dispositivos Smartworld e equipamentos eletroeletrônicos.

Certificados Emitidos MDSAP

 

 

Nº. Certificado Revisão Validade Descrição Regulamento Status
NCC 21.07037 Rev. 00 17/08/2024 Scope: Manufacture, Import, Export, Distribution, Design, Installation, Technical Assistance, Training and Rental of Electromedical and Medicalhospital devices in the Neurosurgery Area, including their Consumables (sterile and non-sterile) and the Development of Software related to the healthcare area. Not applicable items: Item 7.5.9.2 – Particular requirements for implantable healthcare products. ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC 22.09055 Rev. 00 05/01/2025 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. Not applicable items: – 7.5.5: Particular requirements to sterile medical devices
– 7.5.7:Particular requirements to process validation of sterilization and sterile barrier system
– 7.5.9.2: Particular requirements to implantable medical devices
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC 22.09095 Rev. 00 07/02/2025 Scope: Design, manufacturing, technical assistance and distribution of equipment of laser
hair removal. Not applicable items:- 7.5.5: Particular requirements to sterile medical devices; – 7.5.7: Particular requirements to process validation of sterilization and sterile barrier system; – 7.5.9.2: Particular requirements to implantable.
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC 22.07131 Rev. 00 11/03/2025 Scope:”Design, development, manufacturing, importing, salesandpost-marketing supporting of monitoring and diagnostic medical devices”
Not applicable items: 7.5.3: Installation activities; 7.5.5: Particular requirements to sterile medical devices; 7.5.6: Validation of production processes and service provision; 7.5.7: Particular requirements to process validation of sterilization and sterile barrier system; 7.5.9.2 Particular requirements to implantable; 7.5.10: Customer property.
ISO 13485:2016 Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC22.09319 REV.01 24/06/2025 Scope:”Design,development, manufacture, sales and distribution of sterile and disposable instrument kits applicable to otolaryngology,orthopedics surgery and neurosurgery, equipos for ortopedics and sterile surgical electrodes for neurosurgery andortopedics“.
Notapplicableitems:7.5.3: Installationactivities;7.5.4:Servicingactivities(Note:disposable products);7.5.9.2Particular requirements to implantable;7.5.10: Customer property.
ISO 13485:2016 : RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021 ; RDC ANVISA nº67/2009 Ativo
NCC 22.09287 REV.01 17/06/2025 Scope: “Design, development, manufacturing, sales, exportation and distribution of dental
products, diamond burs, carbide Not applicable items: 7.5.3: Installation activities; 7.5.4: Servicing activities;
7.5.9.2: Particular requirements to implantable medical devices; 8.3.4: Rework.
ISO 13485:2016
Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 551/ Brasil: RDC ANVISA nº 16/2013; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
EUA: 21 CFR 820
Japan: MHLW Ministerial Ordinance No.169 (2004) as amended by MHLW Ordinance No. 128 (2014)
Articles 4 to 68; Japan PMD Act (as applicable)
Canada: Medical Device Regulations SOR/98-282, Part 1
Australia: Schedule 3, Part 1 – Full Quality Assurance System; Schedule 3, Part 4 – Production Quality Assurance Procedures
Ativo
NCC 22.09382 REV.00 01/08/2025 Scope: Design, manufacture, storage and distribution of hypothermic
organ preservation solutions
Notapplicableitems:
7.5.2-ProductCleaning
7.5.3-InstallationActivities
7.5.4-TechnicalAssistanceActivities
7.5.9.2-Particularrequirementsforimplantablemedicaldevices
7.5.10-Customerproperty
8.3.4–Rework
ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
EUA : 21 CFR 820.20
Canadá: Medical DevicesRegulations–Part1-SOR 98/282
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