Medical Device Directive Safety 测试

Incorporating requirements from IEC 60601, the Medical Device Directive (2007/47/EC) is a mandatory step in the CE Marking process for medical products ranging from wheelchairs to bandages to diagnostic equipment. The MDD exists to ensure that all devices in the 欧洲an Union are safe and operate without defect.

im体育APP的 电气安全试验 can provide all the services a manufacturer needs to meet the requirements of the MDD. There are key aspects which are mandatory and these must be in place before CE marking to this Directive can take place, 包括: 

• 产品 Safety 测试 to show presumption of conformity to the essential requirements of the LVD
• 技术文件的编译
• Completion of a Declaration of Conformity (DoC) 

We understand that the international standard for Application of Risk Management to 医疗设备 is a mandatory requirement when demonstrating compliance to the 3rd Edition of EN/IEC 60601-1. Without this documentation, compliance to EN/IEC 60601-1 3rd Edition is not possible. We can assist you with this and provide support and 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
• 指导和保留合同

Safety testing for the Medical Device Directive

im体育APP is compliant to the medical safety standard IEC 60601-1, which is recognized by public health authorities the world over and is the harmonized standard for equipment under the Medical Device Directive. We offer impartial third party support to manufacturers in all aspects of the CE Marking Directive; from design consultation, 全面的产品安全检测, Technical File compilation and review. Our necessary to provide vital market advantage and confidence in placing a product on the market. 

Our safety experts understand the challenge of 电气安全试验 of medical products for global export, and assist manufacturers in achieving increased speed to market, resulting in successful product launches. 

For those that need guidance on the regulatory requirements for a particular product, we can provide product certification advisory service services to support them through the testing and approval of their products and components. 

Medical Device Directive Notified Body Services

As a BIS (formerly the DTi) Notified Body under the Medical Device Directive, we provide the testing needed to achieve certification, assistance with the compilation of a technical file, and support for ongoing quality testing.

We also provide Notified body services for the following related directives:

• 电磁兼容指令
• 无线电设备指令(RED)
• 低压指令(LVD)
• Explosive Atmospheres directive (ATEX)

The documentation that we issue is in a recognized format and thus should ensure universal acceptability by enforcement authorities throughout the EU. 

It should be remembered that the incorrect CE marking of products can carry severe penalties both for the company and for the individual responsible for signing the DoC. 

医疗器械指令指南

Covering a wide variety of testing types, the Medical Device Directive applies to a large scope of products. While the current version does not include active 植入式设备 this will change in 2020 with the introduction of the Medical Device Regulation (MDR). Our experts can help you determine how this will affect your products, if you will need to incorporate additional directives or standards, and what you need to do to remain compliant under new legislation.

Further medical device and safety certification services

我们的认证团队提供 认证服务 required for Market Access for many countries throughout the world as well as 欧洲公告机构服务. 

As a 认证 Body Test Laboratory (CBTL) and a National 认证 Body (NCB) under the IECEE scheme, we can test and certify your electrical products to the IECEE认证方案, which has significant market access advantages including reduce test costs and time to market.

im体育APP的 全球市场准入 team provide further services to help those looking to export their products into the Global Market place.