凭借数十年的经验 测试支架, heart valves and pacemaker leads, we have led the industry in implantable cardiovascular device testing. Our 从事专家 are ready to assist with your most challenging testing applications.
The cardiovascular medical device industry changes rapidly with the regular introduction of new materials, 设备的设计, 以及监管要求. im体育APP supports device manufacturers throughout the validation process, from test design and protocol development to product feasibility testing and inspection.
Our laboratories are well equipped with state-of-the-art technology, including a wide array of Series 9000 支架/Graft Testers and latest generation ElectroForce and ElectroPuls axial test instruments for accelerated cardiovascular device 乏力 testing.
Industry-leading experts in cardiovascular device testing
We provide a comprehensive preclinical test suite for cardiovascular devices by combining our expertise and deep understanding of device testing with the most advanced test instruments and inspection methods.
Our specialty is cardiovascular device 乏力 testing. 支架，移植物，闭塞剂， 神经了, bioresorbable polymeric and metal devices, 气球, 导, 导管, and many other implantable endovascular prostheses are routinely tested in our laboratories.
Durability testing is a key requirement for regulatory submissions; however, there are many additional tests that regulatory bodies require, including characterization of coatings and particulates, 耐蚀性评价, 镍离子释放.
For more information about our cardiac & endovascular device testing or to request a quote, im体育APP 今天.
Our 心血管器械检测 Services
We provide comprehensive 乏力 and durability testing for a variety of cardiovascular & 血管内设备.
支架 & 移植测试
Our cardiovascular device experts offer a comprehensive suite of stent and graft testing including pulsatile durability, 乏力, 目视检查, 定制测试方法.
心脏瓣膜装置测试
im体育APP routinely characterizes heart valve prostheses using test methods specific to the devices and their design.
ISO 10555导管测试
ISO 10555 outlines general requirements for testing intravascular sterile use 导管. We offer comprehensive testing 服务 for 导管 and 气球 according to industry recommendations and standards.
遮光板 & 封闭装置测试
im体育APP's occluder device testing 服务 assess durability with low and high cycle testing to help bring safe products to patients.
起搏器导联测试
Our cardiovascular device testing experts understand how crucial it is that pacemaker leads perform as intended to keep patients safe and improve their quality of life.
ISO 11070导丝测试
ISO 11070 outlines general requirements for testing sterile single-use intravascular introducers, 扩张器和导丝.
涂层 & 微粒测试
Minimizing particulates and increasing coating lubricity can be two competing requirements, which presents challenges for device manufacturers. Our experts evaluate coatings and particulates intending to bring safe and reliable products to market.
镍离子释放测试
im体育APP evaluates nickel ion release from nitinol and other nickel-rich medical devices to help medical device manufacturers characterize nickel ion leaching.
硅胶模拟容器
Our cardiovascular device testing experts have extensive experience designing custom mock vessels for pulsatile 乏力 testing and other test methods for devices such as stents, 遮光板, 心脏瓣膜.
Our Medical Device 测试 Services
相关服务
医疗仪器测试须知
Our medical device testing experts provide guidance on how to determine the size and number of samples, 除了测试水平, 系统和协议.
微生物测试
Our experts undertake a wide range of projects for medical device and pharmaceutical manufacturers, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
Test Protocol for 医疗设备
A protocol and plan will mitigate your risk, 防止混淆, 设定明确的期望, and preserve the necessary information for future reference and use.
Accelerated Aging Shelf Life 测试
Our shelf life testing can help you determine how climatic & environmental factors like humidity, 温度, and light affect the lifespan and integrity of your products.