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将创新的医疗设备技术推向市场是一项高风险的冒险. 这就是为什么Element通过为客户的医疗器械测试需求提供准确可靠的结果,努力提供绝对的测试确定性, from small, start-up ventures to large, established manufacturers.
我们的医疗设备测试全产品生命周期方法
Element支持医疗器械测试的每个阶段-从测试协议开发和原型/可行性试验到测试和咨询:
Our turnkey invasive and non-invasive physiological monitoring studies 涵盖整个产品生命周期,从R&D进行监管提交的验证.
使用Element的医疗器械试验方法
我们提供全套医疗设备测试,包括:
- mechanical testing
- product testing
- clinical validation testing
- material characterization
- microbiological evaluation.
作为全面的医疗器械测试合作伙伴, 您将享受到单一供应商满足您所有测试需求的好处, from feasibility and R&负责产品开发和生产质量控制.
您可以信赖的医疗设备测试解决方案
我们的专家团队在广泛的测试服务方面拥有多年的经验, I, II和III医疗器械,以帮助您符合法规,并确保您的医疗器械产品的每个方面都经过适当的测试.
Contact us today 了解Element如何为您的医疗器械提供测试服务和咨询.
Our Medical Device Services
Element为医疗器械im体育平台app下载提供最全面的材料和产品测试服务.
![Orthopedic Device Testing 640 x 480](/-/media/images/services/product-testing/orthopedic-device-testing-640-x-480.jpg?h=283&w=378&la=en&hash=2D415F26E3C4098BC09E4A830E504BAE)
Orthopedic Implant Testing
作为骨科植入物检测的全球领导者, Element在评估髋关节置换术方面有多年的经验, knee prostheses, 脊柱装置和许多其他植入物.
![Cardiovascular Device Testing 640x480](/-/media/images/services/materials-testing/cardiac-endovascular-device-testing640x480.jpg?h=283&w=378&la=en&hash=2FFC05102361BA6A64EB0D3E0BC8B830)
Cardiovascular Device Testing
Element专注于心血管设备的广泛测试, such as stents, grafts, occluders, catheters, heart valves and pacemaker leads.
![EMC testing](/-/media/images/services/product-testing/medical-device-testing-card-emc-testing.jpg?h=283&w=378&la=en&hash=F89AB17E7C6B8E4ED0100D2FE377C874)
EMI & EMC Testing
Element为各种医疗设备和组件执行电磁兼容性(EMC)和电磁干扰(EMI)测试, including implantable devices, 诊断工具和治疗设备.
![Medical Device Reprocessing](/-/media/images/sectors/medical-device/rmd-640x480.jpg?h=283&w=378&la=en&hash=D526345BF009D41806FC2EE98CA98F40)
可重复使用医疗器械后处理验证和测试
Every Reusable Medical Device must be reprocessed before reuse to minimize risk of contamination; this includes cleaning and either sterilization or disinfection.
![reusable medical device validation](/-/media/images/services/materials-testing/reusable-medical-device-validation-640x480.jpg?h=283&w=378&la=en&hash=6D7D903F69836EFD441A164CA804EEA3)
可重复使用医疗器械生命周期验证
我们的医疗器械专家在经过多次高压灭菌器灭菌循环后,评估可重复使用的医疗器械对识别标记和功能的环境影响.
![自动化化学相容性测试](/-/media/images/sectors/medical-device/automated-chemical-compatibility-testing-640-by-480.jpg?h=283&w=378&la=en&hash=A6703FA30B60E6367EFF2EAEFF915E06)
医疗器械、材料和表面的化学相容性测试
Element可以提供自动化化学兼容性测试,为医疗器械与医用消毒剂的兼容性提供更快、更可靠的结果.
![药物试验,萃取物和浸出物](/-/media/images/sectors/pharmaceuticals/pharma-extractables-and-leachables-480x640.jpg?h=283&w=378&la=en&hash=022B1736643EC59294111EEFCCABA181)
Extractables and Leachables Studies
Element的可萃取物和可浸出物研究提供量身定制的解决方案,确保患者安全并符合im体育平台app下载标准.
![Microbiological Analysis 640x480](/-/media/images/services/materials-testing/microbiological-testing-640x480.jpg?h=283&w=378&la=en&hash=5D340EEFFB19A72B31417FA9E6CD8CB0)
Microbiological Analysis
Element为医疗设备提供广泛的微生物分析项目, 从病原体和生物负荷检测到内毒素和细胞毒性分析.
![rated burst pressure 640x480](/-/media/images/sectors/medical-device/rated-burst-pressure-testing-mdt-640x480.jpg?h=283&w=378&la=en&hash=0ED9DE7B9311E539C86E65A1E17B12E0)
Rated Burst Pressure & Leak Testing
Element专业从事医疗设备的额定爆裂压力和泄漏测试, including catheters, balloons, valves, medical bags, tubing, and connectors.
![加速老化保质期测试640x480](/-/media/images/services/product-testing/medical-device-testing-card-5-accelerated-aging-shelf-life-testing.jpg?h=283&w=378&la=en&hash=1A3EFF834EA51B6A1976FBD9D005A312)
Accelerated Aging Shelf Life Testing
我们的保质期测试可以帮助您确定气候和环境因素,如湿度, temperature, 光会影响你的产品的寿命和完整性.
![医疗设备电池测试640x480](/-/media/images/services/product-testing/medical-device-testing-card-6-medical-device-battery-testing.jpg?h=283&w=378&la=en&hash=BB853D162B3E570EFD7CAE041CD1BDAE)
Medical Device Battery Testing
Element为医院和家庭健康应用中使用的可充电锂离子电池和镍氢电池提供安全和认证测试.
![IEC 60601医疗器械安全测试640x480](/-/media/images/services/product-testing/medical-device-testing-card-8-iec-60601-medical-device-safety-testing.jpg?h=283&w=378&la=en&hash=371C73BE3B02895D1E50426E7580699C)
IEC 60601 Safety Testing
Element提供全套医疗器械测试和认证服务,确保您满足全球公认的必要的IEC 60601产品安全要求.
![](/-/media/images/services/product-testing/medical-device-testing-card-regulatory-services.jpg?h=283&w=378&la=en&hash=2000A38D28620981DA4A7A54890782F8)
Medical Device Regulatory Services
我们的医疗器械监管专家帮助医疗器械制造商进行产品注册, quality management systems, and in-country and global approvals.
![Connected Technologies - Medical](/-/media/images/sectors/connected-technologies/ct-medical-640-x-480.jpg?h=283&w=378&la=en&hash=BA78F3B3AEF057B28AFB71034692A2EE)
Clinical Validation Testing
通过Element针对医疗设备和可穿戴设备的全套侵入性和非侵入性生理监测研究,专注于发展您的业务.
![](/-/media/images/services/materials-testing/syringe-testing-640x480.jpg?h=283&w=378&la=en&hash=0771022D428DC7A66300FE04C278F31F)
![IS0 18562-2](/-/media/images/sectors/life-sciences/is0-18562-2-640x480px.jpg?h=283&w=378&la=en&hash=C5AE08E5E72438CA95A5607477DB3998)
ISO 18562测试:生物相容性分析
Element为呼吸和通风设备提供ISO 18562生物相容性分析,以支持全球设备批准.