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, 创业企业发展壮大, 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), CE标志, and other regulatory submissions.
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, 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, 如支架, 移植, 遮光板, 导管, heart 阀门 and pacemaker leads.
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, 包括植入式设备, diagnostic tools and therapeutic equipment.
Reusable Medical Device Validation
Our medical device experts evaluate the environmental impact on the identification markings and function of reusable medical instruments after repeated autoclave sterilization cycles.
化学兼容性测试 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 provides a wide range of microbiological analysis projects for medical devices, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
额定爆破压力 & 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.
Accelerated Aging Shelf Life 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.
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.
Medical Device Regulatory Services
Our medical device regulatory experts help manufacturers of medical devices with product registrations, 质量管理体系, and in-country and global approvals.
Test Protocol for 医疗设备
A protocol and plan will mitigate your risk, 防止混淆, 设定清晰的期望, and preserve the necessary information for future reference and use.
Preparing for a medical device testing program can be a challenge for many manufacturers, especially if it is a new or novel product or if time is limited. Our medical device experts share their testing tips and best practices.
发现博客文章, 文章, 白皮书, 在线研讨会, and advice from our world-leading testing, 检查, 和认证专家.
Learn more about our laboratories - where they are located; the unique capabilities they have and how they can help you solve your technical and commercial challenges.