IEC 60601医疗设备安全测试

在世界各国使用, IEC 60601 helps ensure the safety 和 effectiveness of electrical 和 electronic medical devices. 我们利用我们的 产品资格 和 EMC expertise to help ensure that your medical devices 和 products are in compliance with IEC 60601 st和ards, 并准备出口到全球市场.

Combining industry experience with state-of-the-art laboratory testing facilities, im体育APP provides a full suite of medical device testing 和 认证 services to ensure that you meet the necessary IEC 60601 product safety requirements recognized across the world. 我们的 services span from product design 和 prototype evaluation to formal compliance testing, 认证, 以及持续的标准和监管建议.  

im体育APP can help you at any stage of your medical device project ensuring the best 认证 option for your product, 你的市场, 还有你的生意.  

IEC 60601医疗安全测试服务

Some of our IEC 60601医疗安全测试服务 include, not limited to: 

• Training support for IEC 60601 - customized in-house or onsite training at customer premises
• Gap assessment to 60601 series, IEC62304, IEC62366, ISO14971, 和 other st和ards
• 咨询服务 符合IEC 60601标准
• 测试报告和证书 IECEE CB方案 
• Risk management 和 integrated quality system (ISO 13485 和/or ISO 14971) assessments
• IECEE CB认证为国际CB认证体系
• Software 和 usability assessments to support various IEC 60601 clauses
• 根据IEC 60601-1-2进行EMC测试和评估
• 支持IEC 60601-1-11的家庭保健评估
• I、IIa、IIb和III类设备的CE标志

Design 和 safety testing of electrical 和 electronic medical devices  

Before we can categorize new devices as ‘safe’ for use in a medical working environment 和 brought to market, it is necessary to determine if a device can perform safely 和 effectively without causing harm 和/or electromagnetic disturbances in its appropriate operating environment. 

支持产品开发生命周期的早期阶段

im体育APP’s 从事专家 can help you with determining which st和ards apply to your device, 评估你的设计规范是否符合要求, 和 introduce an efficient risks management program right from the beginning of the project. We also offer additional support 和 guidance to start–up companies during their first stages of medical device development 和 design, ensuring barriers to entry are addressed as early as possible 和 a solid regulatory 和 go-to-market strategy is developed.

风险评估和档案管理

We offer impartial third-party support in all aspects of product development, 来自设计咨询, 全面的产品安全检测, 并完成合格声明(DoC), 负责技术文件的编写和审核. With world-class expertise in electrical 和 electronic medical device testing, our specialists provide you with consultative guidance 和 feedback throughout the whole product development process so you can be confident in placing your product on the market.  

符合ISO 14971标准   

The application of risk management to medical devices is a m和atory requirement when demonstrating compliance with the IEC 60601 series of st和ards. 没有这个文档, compliance is not possible; we can assist you with this 和 provide support 和 guidance on ISO 14971 risk management, 包括:

• 定制和一对一培训
• 文件和程序审查
• 制作重要文件
• 差距分析、补救 & 缓解 

电气医疗器械的CE标志

im体育APP’s experts provide you with guidance through every step of the CE认证程序 for medical devices, ensuring successful 和 efficient product launches. 

CB体系认证 & IEC 60601的CE标志

IECEE CB 认证 addresses most CE Marking requirements for medical 和 electronic equipment safety in 欧洲, 和 means that you only have to test your product once at a single location. 

拥有超过20年的经验，im体育APP是一家领先的 IECEE CB证书 covering a wide range of 认证, including the IEC 60601 series for medical equipment. We are a National Certificate Body (NCB) 和 can provide internationally recognized certificates based on testing from our associated CB Scheme testing laboratories (CBTL) in the UK, 美国, 德国, 和中国. 

全球市场准入的全球审批

我们的 全球市场准入(GMA) experts underst和 the challenge of safety testing of medical products for international export 和 assist manufacturers with 3rd party testing, 郡表示, 产品翻译, 和 more to achieve increased speed to market for successful product launches. 

For more information about our IEC 60601医疗设备安全测试 services, 或者要求报价, 立即im体育APP.