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Bringing innovative medical device technology to the marketplace is a high‐risk venture. That’s why im体育APP strives to provide absolute testing certainty by delivering accurate and reliable results for our clients’ medical device testing needs, 从小型, 初创企业规模过大, 建立了制造商.
Our full product life cycle approach to medical device testing
im体育APP supports every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing and consultation for:
我们交钥匙侵入式和非侵入式 生理监测研究 涵盖整个产品生命周期，从R&D进行监管提交的验证.
使用im体育APP的医疗器械试验方法
We offer a full suite of medical device testing, including:
As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all your testing needs, 从可行性和R&D to product development and production quality control.
Medical device testing solutions that you can trust
Our dedicated team of experts have years of experience in a wide range of testing 服务 for Class, I, II and III medical devices to help you meet regulations and ensure that every aspect of your medical device product is properly tested.
立即im体育APP to learn how im体育APP can provide testing 服务 and consultation for your medical device.
我们的医疗仪器服务
im体育APP offers the most comprehensive range of materials and product testing 服务 for the medical device industry.
骨科植入物测试
As a global leader in orthopedic implant testing, im体育APP has years of experience in evaluating hip replacements, 膝关节假体, 脊柱装置和许多其他植入物.
心血管器械检测
im体育APP specializes in a wide range of testing for cardiovascular devices, 比如支架, 移植, 遮光板, 导管, 心脏瓣膜和起搏器导线.
产品 Specific Regulatory Compliance RoadMap
RegNav combines expert insights with AI software, giving you a detailed picture of your medical device’s safety and performance requirements.
EMI & 电磁兼容测试
im体育APP performs electromagnetic compatibility (EMC) and electromagnetic interference (EMI) testing for a variety of medical devices and components, 包括植入式装置, 诊断工具和治疗设备.
Reusable 医疗器械后处理 Validation and 测试
Every Reusable 医疗设备 must be reprocessed before reuse to minimize risk of contamination; this includes cleaning and either sterilization or disinfection.
Reusable 医疗设备 Life Cycle Validation
Our medical device experts evaluate the environmental impact on the identification markings and function of reusable medical instruments after repeated autoclave sterilization cycles.
化学相容性测试 for 医疗设备, Materials, and Surfaces
im体育APP can offer automated chemical compatibility testing that gives faster and more reliable results for medical device compatibility with medical disinfectants.
可萃取物和可浸出物研究
im体育APP's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
微生物分析
im体育APP provides a wide range of microbiological analysis projects for medical devices, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
额定爆裂压力 & 泄漏测试
im体育APP specializes in performing rated burst pressure and leak testing for medical devices, 包括导管, 气球, 阀门, 医疗包, 油管, 和连接器.
加速老化保质期测试
Our shelf life testing can help you determine how climatic and environmental factors like humidity, 温度, and light will affect the lifespan and integrity of your products.
医疗设备电池测试
im体育APP provides safety and certification testing for rechargeable lithium-ion and nickel metal hydride batteries used in hospital and home health applications.
IEC 60601安全测试
im体育APP provides provide a full suite of medical device testing and certification 服务 to ensure that you meet the necessary IEC 60601 product safety requirements recognized across the world.
医疗仪器规管服务
Our medical device regulatory experts help manufacturers of medical devices with product registrations, 质量管理体系, 以及国内和全球的批准.
临床验证试验
Focus on growing your business with im体育APP’s turn-key invasive and non-invasive physiological monitoring studies of medical devices and wearables.
注射器测试
With extensive experience evaluating prefilled syringes and autoinjector components for functionality and integrity, im体育APP can help you successfully navigate regulatory requirements for testing.
分析测试服务
We offer a comprehensive array of analytical testing 服务 and expert scientific consultancy from our GMP/GLP and ISO/IEC 17025 accredited laboratories, to meet the needs of clients across the life sciences sector.
生命科学
Check out our 生命科学 thought leadership content including webinars, 白皮书, 案例研究、博客等等.
由我们的im体育平台app下载专家撰写, we tackle a range of subjects across 抗菌, 生物技术食品, 医疗设备, 制药, 和个人护理im体育平台app下载.
带着对绝对确定性的承诺, we utilize our extensive expertise and experience to provide insights that ensure the safety of materials used in the life science sector.
im体育官方app下载