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 NVLAP, 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.
IEC 60601 Medical Device Safety Testing
We leverage our product qualification and EMC expertise to help ensure that your medical devices and products are in compliance with IEC 60601 standards, and ready for export to global markets.
Find out more about Element's global platform of laboratories to ensure that you have the facilities, technical expertise and procedures to ensure that your products comply with national and international industry-specific and legislative EMC standards.
CE Marking and Testing
CE marking is a mandatory conformity mark enabling you to enjoy free movement between all 28 Member states.
Local laboratories, global platform
Doing business with one of our laboratories enables our clients' access to our global platform of expertise, capacity and capabilities.
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