Medical Device EMC Testing

We test a comprehensive range of medical equipment including Class I, II, and III electronic devices with varying risk profiles. Our specialized testing covers devices with integrated wireless capabilities such as MedRadio applications, Wireless Medical Telemetry, RFID technologies, and those utilizing Wi-Fi, Bluetooth, and GSM communications – all critical for today's connected healthcare environment. Our expertise spans across both basic medical equipment and sophisticated devices that require rigorous EMC evaluation to maintain essential performance in complex electromagnetic environments. 

• Electronic medical devices across all risk classifications 

• Wireless medical devices with various communication protocols 

• Medical equipment requiring CE marking and FDA 510(k) submissions 

• Devices needing international IECEE CB certification 

Our medical device EMC testing services address both emissions and immunity requirements essential for regulatory compliance. We provide comprehensive electromagnetic compatibility testing according to IEC 60601-1-2 standards, specialized wireless coexistence assessments following ANSI C63.27, and RFID evaluations according to AIM 7351731 protocols. Our testing validates that your devices maintain basic safety and essential performance in electromagnetic environments, supporting both domestic and international regulatory submissions including FDA 510(k), EU Medical Device Directive (93/42/EEC), and CE marking for Class I through III devices. 

• EMC emissions and immunity testing per IEC 60601-1-2 

• Wireless coexistence assessments according to ANSI C63.27 

• Radio Frequency Identification (RFID) evaluations per AIM 7351731 

• Global regulatory compliance testing for multiple markets, including CISPR 11 and 32 EMC requirements 

We work with you from product conception through prototype evaluation to full certification, providing tailored testing strategies that address your specific device requirements. Our approach harmonizes different testing requirements for multiple regulatory submissions simultaneously, reducing redundant testing while maintaining compliance across global markets. Our specialized Regulatory Affairs team provides support and guidance including ISO 14971 risk management, identifying appropriate requirements for your specific medical device and removing both cost and risk from medical product verification and validation during formal testing phases. 

• Integrated testing strategies for multiple market submissions 

• Risk management support compliant with ISO 14971 

• Regulatory affairs guidance through certification processes 

• Prototype evaluation for early compliance assessment 

• Harmonized testing requirements for international submissions 

Wireless medical device expertise 
Our specialized knowledge in wireless medical device testing addresses the unique challenges of connected healthcare technology. When wireless functionality is added to a medical device, wireless coexistence assessments become a mandatory part of ensuring basic safety and essential performance. We understand the critical nature of wireless coexistence in medical environments and provide comprehensive assessments according to ANSI C63.27 standards. We can integrate many technologies into our testing, including MedRadio, Wireless Medical Telemetry, RFID, Wi-Fi, Bluetooth, and GSM radio applications. This expertise helps you confidently implement wireless functionality while maintaining basic safety and essential performance, particularly important as many manufacturers look to add wireless features to their existing medical products. 

Our laboratories are equipped with advanced EMC testing chambers and specialized equipment designed specifically for medical device evaluation. These facilities allow for accurate measurement of electromagnetic emissions and immunity across various frequencies and intensities, creating controlled environments that precisely replicate real-world electromagnetic conditions your devices will encounter. Our testing capabilities span the full spectrum of requirements in the EN/IEC 60601 series, ANSI C63.27 wireless coexistence standards, and other applicable medical device EMC requirements. 

Element provides Medical Device EMC testing through our accredited laboratories strategically located in the US, UK, and Germany. Each facility maintains ISO/IEC 17025:2005 accreditation from recognized bodies including A2LA, UKAS, or DAkkS, along with approval to ISO 9001:2008 standards. Our laboratories are designated as National Certification Bodies (NCB) and Certification Body Test Laboratories (CBTL) under the IECEE's Worldwide System for Conformity Testing and Certification specifically covering medical products, ensuring consistent quality and acceptance of test results across global markets.