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.
im体育APP supports every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing and consultation for 510 (k)测试, CE标志，及其他 医疗器械监管意见书. Our turnkey invasive and non-invasive 生理监测研究 apply to the entire product lifecycle, from R&D to validation for regulatory submission.
Full product life cycle approach to medical device testing methods
As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all of your testing needs, 从可行性和R&D to product development and production quality control. We offer a full suite of medical device testing, including 机械测试, 产品测试, 临床验证试验, material characterization and microbiological evaluation.
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.
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, spinal devices and many other implants.
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.
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, diagnostic tools and therapeutic equipment.
Reusable 医疗器械后处理 Validation and 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 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.
im体育APP's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
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.
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.
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.
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.
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.
Focus on growing your business with im体育APP’s turn-key invasive and non-invasive 生理监测研究 of medical devices and wearables.
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.
im体育APP provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.