Medical Device 电磁兼容测试

im体育APP is the perfect partner for EMC testing, 认证 and global approvals of your Class I, II, and III electronic medical devices. 

Medical device EMC testing and 认证 services

• Medical Device Battery 测试
• Microbiological Analysis 
• 电磁兼容测试 
• 产品 Safety 测试 
• Radio and Wireless 测试 
• 环境测试 
• International IECEE CB 认证
• CE mark of class I, IIa, IIb and III devices
• EMC emissions and immunity testing 

Wireless medical devices testing 

Many medical device manufacturers are looking to add wireless features to their existing products. im体育APP is a well-established leader to help you achieve the necessary regulatory approvals for your wireless medical devices. 

We can integrate many technologies into our medical device testing, some of the applications that we work with include; MedRadio, Wireless Medical Telemetry, 射频识别, 以及Wi-Fi®, 蓝牙®, and GSMTM radio applications.  

When wireless functionality is added to a medical device, wireless co-existence assessments become a mandatory part of ensuring basic safety and essential performance. im体育APP has developed a range of test suites to test these aspects.

Harmonized standards for medical devices

• EN/IEC 60601系列 
• ANSI C63.27 on wireless coexistence
• AIM 7351731 on Radio Frequency Identification (射频识别) assessments
• US 食物 and Drug Administration (FDA) 510(k)
• Medical Device Directive (MDD)
• Specialist Regulatory Affairs team to provide support and guidance including ISO 14971 risk management

With our deep knowledge of international standards, regulatory expertise and access to a global network of laboratories, we can harmonize different testing requirements for regulatory submissions and other essential 认证s to meet your testing needs, wherever the product is to be sold in the world. 

缩短产品上市时间 

From the conception of products to prototype evaluation, testing and right through to full compliance and 认证, we work with you to identify the appropriate requirements for your specific medical device. This removes both the cost and risk from medical product verification and validation during the formal testing phase, bringing your products to market quickly as a result.

im体育APP优势 

im体育APP works with manufacturers of electrical medical devices to identify the testing, 认证, and evaluation needed for compliance to electromagnetic compatibility and safety standards, and international regulations. We offer rigorous testing to international standard IEC 60601-1-2 to ensure adequate electromagnetic safety, performance and effectiveness of your medical devices and electrical equipment for quick Global Market Access (GMA). 

Our EMC laboratories in the US, 英国, and Germany hold a range of accreditations and approvals including ISO/IEC 17025:2005 from NVLAP, A2LA, UKAS, 或DAkkS, approval to ISO 9001:2008, National 认证 Body (NCB) and 认证 Body Test Laboratory (CBTL) under the IECEE’s Worldwide 系统 for Conformity 测试 and 认证 of Electronic Equipment and Components, covering MED – specifically medical products.

For more information about our medical device testing services, or to request a quote, 立即im体育APP.