• 认证服务

    3Q&验证

    此服务为有偿服务，对于适用此服务的仪器、设备，用户可以自由选择在任一时间购买此服务以开展对您的仪器、设备的3Q验证服务
    This is a paid service. For instruments and equipment eligible for this service, users can freely choose to purchase it at any time to conduct 3Q verification on their instruments and equipment.

    3Q 验证通过安装确认（IQ）、运行确认（OQ）、性能确认（PQ）递进流程构建设备质量体系，契合赛吉生物科研仪器的质量定位。IQ 聚焦合规落地，如核对 RSED 系列胚胎培养系统的三气控制模块、温度管理系统与技术文档一致性，确认安装环境符合 GMP 级温湿度、通风要求；OQ 以极限测试验功能，例对科研用 RSED 系列胚胎培养箱做压力耐受与气体浓度校准精度检测；PQ 结合场景核验，如验证胚胎培养系统 0.2℃温差控制能力。该服务适配干细胞培养系统、胚胎培养系统、微重力模拟系统以及类器官培养系统等。
    3Q verification establishes an equipment quality system via the progressive process of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), aligning with the quality positioning of Sage Bio's scientific research instruments. IQ focuses on compliant deployment—e.g., verifying consistency between components (three-gas control modules, temperature management systems) of RSED series embryo culture systems and technical documents, and confirming installation environments meet GMP requirements for temperature, humidity, and ventilation. OQ validates functionality through limit testing, such as pressure tolerance and gas concentration calibration accuracy tests for research-grade RSED series embryo incubators. PQ verifies scenario-based performance, like validating the 0.2℃ temperature difference control capability of embryo culture systems.This service is suitable for stem cell culture systems, embryo culture systems, microgravity simulation systems, and organoid culture systems.
    3Q 验证是赛吉服务体系保障科研实验室可靠性的核心，价值贯穿科研仪器全生命周期。对干细胞研究实验室，PQ 阶段长期稳定性测试确保 RSED 系统模拟的子宫（动物，如小鼠）环境参数精准，为类器官构建提供可复现的实验基础；对细胞生物学实验室，校准试剂配套设备的检测阈值，提升实验数据可信度。完整验证文档可追溯设备安装、运行全流程数据，助实验室满足 GLP/GMP “数据完整性” 要求，规避因设备问题导致的实验结果不可重复风险。
    3Q verification is core to Sage’s service system, safeguarding research lab reliability throughout the scientific instrument lifecycle. For stem cell research labs, long-term stability testing in the PQ phase ensures precise uterine environment (animal, e.g., mouse) parameters simulated by RSED systems, providing reproducible foundations for organoid construction. For cell biology labs, calibrating the detection thresholds of reagent-matched equipment enhances the credibility of experimental data.Comprehensive verification documents can trace the full-process data of equipment installation and operation, helping laboratories meet the "data integrity" requirements of GLP/GMP and avoiding the risk of irreproducible experimental results caused by equipment issues.

    CE&认证

    赛吉生物始终聚焦海外市场布局，公司对产品核心材料及各类零配件的可靠性与稳定性予以高度关注，建立了严格的筛选标准与检测流程。同时，安排了专业技术人员全程协助开展 CE 认证，认证文件随产品同步交付，确保满足目标市场（有CE要求）法规要求。
    Sage-Bio has always focused on its overseas market layout. The company attaches great importance to the reliability and stability of the core materials and various components of its products, and has established strict screening standards and testing procedures. Meanwhile, it has arranged professional technical personnel to assist in CE certification throughout the process, and the certification documents are delivered alongside the products to ensure compliance with the regulatory requirements of target markets (where CE requirements apply).

    器械备案