5. IVD Medical Devices

医疗器械委托研发与生产

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我们拥有一支由资深工程师、医学专家和科研人员组成的强大研发团队及合作伙伴。具备丰富的医疗器械研发经验,熟悉各类医疗技术和法规要求,能够为您的项目提供专业的技术支持。团队成员和合作伙伴涵盖多个专业领域,包括机械设计、电子工程、软件、生物医学工程等,确保从不同角度对医疗器械进行全面优化 。合作伙伴拥有现代化的生产车间和先进的生产设备,能够满足不同类型医疗器械的生产需求。

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Our R&D team comprises experienced engineers, medical experts, and researchers with extensive medical device development expertise. We are well-versed in various medical technologies and regulatory requirements, providing professional technical support for your projects. The team's diverse specializations, including mechanical design, electronic engineering, software, and biomedical engineering, ensure comprehensive medical device optimization. Our partners offer modern production facilities and advanced equipment to meet diverse medical device manufacturing needs.

a. AI-assisted Softwares

医疗器械(含AI)开发/注册

我们的团队结合人工智能技术和法规事务方面的专业知识,为您提供从开发到市场进入的无缝体验。我们确保您的创新医疗解决方案不仅利用最新的人工智能功能,而且符合所有必要的法规,为市场批准和采用铺平道路。

Our team blends AI expertise with regulatory knowledge, offering a comprehensive service from development to market launch. We ensure your innovative medical solutions harness cutting-edge AI while meeting all regulatory requirements, paving the way for swift market approval and adoption.

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b. Medical Devices R&D

医疗器械(设备)开发/注册

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b. IVD Reagents

体外诊断(试剂)

我们代理因诺赛生(ImmuthY)全线IVD抗原与抗体产品。此外,通过我们自有的重组蛋白表达和抗体研究平台,我们可为您定制特殊的体外诊断蛋白原料。

We provide ImmuthY's IVD antigens and antibodies. Our platforms enable custom protein development for in vitro diagnostics, tailored to your specifications.

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Viral Antigen & Antibody

病毒抗原与抗体

> DETAILS
Tumor Antigen & Antibody

肿瘤抗原与抗体

> DETAILS
Cytokines

细胞因子

> DETAILS

c. IVD Medical Devices

体外诊断医疗器械

成功项目:开发猴痘病毒快速测试 我们采用原核表达系统生产和纯化抗原蛋白。随后,进行动物免疫,并利用杂交瘤技术和亚克隆筛选方法识别和验证高特异性抗体。最后,应用侧流免疫层析技术开发快速、准确的猴痘诊断医疗器械。

Example Case: Monkey Pox Express and purify antigen proteins using prokaryotic systems, then proceed with animal immunization, hybridoma preparation, and subclone screening to discover and validate specific antibodies. Finally, develop rapid test reagents using lateral flow immunochromatography.

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c. IVD Medical Devices

体外诊断医疗器械

成功项目:我们采用原核表达系统生产和纯化猴痘病毒抗原蛋白。随后,进行动物免疫,并利用杂交瘤技术和亚克隆筛选方法验证高特异性抗体。最后,应用侧流免疫层析技术开发快速、准确的猴痘诊断快速测试医疗器械。

Example Case: Express and purify monkey pox antigen proteins using prokaryotic systems, then proceed with animal immunization, hybridoma preparation, and subclone screening to discover and validate specific antibodies. Finally, develop rapid test medical devices using lateral flow immunochromatography technology.

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d. Others 其它类型

Active Medical Devices

有源医疗器械

获批项目: 乳腺活检定位装置 · 导航手术机器人 · 病理扫描设备 · 超声止血刀系统 · 脑机接口

Examples: Stereotactic breast biopsy device · Surgical navigation robot · Pathology scanning equipment · Ultrasonic cutting and hemostasis system · Brain-computer interface

Passive Medical Devices

无源医疗器械

获批项目: 口腔正畸材料及制品 · 创伤外科辅助器械 · 创伤外科辅助器械  · 手术吻缝合器械

Examples: Orthodontic materials and products · Trauma surgery auxiliary instruments · Trauma surgery auxiliary instruments · Surgical anastomosis and suturing instruments

  • 微信号 / wechat ID: shangjinbiomedical
  • E-mail: consultants@shangjin-biomedical.com
  • Address: 5/F, Block 1, Hang Tai Yue South China Medical Valley Industrial Park, Guangming District, Shenzhen, China
  • 地    址: 深圳市光明区华南医谷恒泰裕大厦一栋五楼
微信 / Wechat ID
shangjinbiomedical

E-mail
consultants@shangjin-biomedical.com

Address
5/F, Block 1, Hang Tai Yue South China Medical Valley Industrial Park, Guangming District, Shenzhen, China

地址
中国深圳市光明区华南医谷恒泰裕1栋5楼
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