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Element is the perfect partner for EMC testing, certification and global approvals of your Class I, II, and III electronic medical devices. 

Medical device EMC testing and certification services

• Medical Device Battery Testing
• Microbiological Analysis 
• EMC Testing 
• Product Safety Testing 
• Radio and Wireless Testing 
• Environmental Testing 
• International IECEE CB certification
• 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. Element 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, RFID, as well as Wi-Fi®, Bluetooth®, 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. Element has developed a range of test suites to test these aspects.

Harmonized standards for medical devices

• EN/IEC 60601 series 
• ANSI C63.27 on wireless coexistence
• AIM 7351731 on Radio Frequency Identification (RFID) assessments
• US Food 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 certifications to meet your testing needs, wherever the product is to be sold in the world. 

Reduced time to market 

From the conception of products to prototype evaluation, testing and right through to full compliance and certification, 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.

The Element advantage 

Element works with manufacturers of electrical medical devices to identify the testing, certification, 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, the UK, and Germany hold a range of accreditations and approvals including ISO/IEC 17025:2005 from A2LA, UKAS, or DAkkS, approval to ISO 9001:2008, National Certification Body (NCB) and Certification Body Test Laboratory (CBTL) under the IECEE’s Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components, covering MED – specifically medical products.

For more information about our medical device testing services, or to request a quote, contact us today.