Struggling to meet global EMC regulations and access major markets for your medical devices? Fear not. Element is here to help.
From product conception to full compliance and certification, we guide you through the entire process pain-free, ensuring your devices meet all necessary standards and reach the market quickly and safely.
Benefits of Medical Device EMC Testing
- Ensure reliable and safe medical device operation
- Enhance patient safety and prevent product failures
- Achieve regulatory approval and certification
- Meet mandatory EMC requirements and standards
- Identify and mitigate electromagnetic interference (EMI) risks
- Obtain globally recognised certifications for market access
- Increase medical device reliability and performance
- Detect EMI issues early, cutting costs and time to market
- Gain a competitive edge with demonstrated reliability, safety, and compliance
- Improve the durability and longevity of medical devices
How Element Can Help You
- Regulatory Compliance: Ensure your devices meet highly stringent medical standards, such as IEC 60601-1-2, for comprehensive safety and performance.
- Medical Device Expertise: Benefit from our deep knowledge of medical device regulations, including FDA 510(k) submissions and Medical Device Directive (MDD) compliance.
- Accredited Global Laboratories: Experience the convenience of our EMC laboratories in the US, UK, and Germany, accredited to ISO/IEC 17025, ISO 9001, NCB, and CBTL standards.
- Global Harmonization: Our expertise in international standards allows us to harmonize different testing requirements for certifications worldwide
- Accelerated Market Entry: Reduce cost and risk with our streamlined process, speeding up your device’s entry to market.
- Risk Management: We conduct thorough risk assessments to ensure devices are safe for patients or healthcare providers.
- Comprehensive Services: Element provides EMC testing, certification, and global approvals for Class I, II, and III electronic medical devices.
- Dedicated Support and Clear Communication: Our EMC experts guide you through the entire process, addressing technical challenges, and keeping you informed.
- Detailed Documentation and Traceability: Receive comprehensive documentation, detailed test reports, and traceability for regulatory submissions and audits.
- Efficient and Cost-Effective Solutions: Enjoy quick turnaround times and competitive pricing without compromising on the quality or integrity of testing services and product performance.
Contact us today to find out more about how we can help you.
Contact Us for Your EMC Testing Needs
Complex standards, tight deadlines, & technical challenges? We're here to help! Let's tackle your EMC testing together!
Why Choose Element for your EMC Testing
Over 25 years of expertise in addressing technical challenges and navigating complex EMC regulations.
Responsive, communicative, and proactive customer service, always there to address your concerns.
Trusted industry leader in EMI and EMC Testing, compliance and certification, delivering reliable services.
ISO/IEC 17025- accredited laboratories ensure compliance and enhance product performance, safety and reliability.
Extensive network of laboratories across the US, UK, and Germany for comprehensive services to meet your local needs.
Full suite of testing and certification services from the initial concept to market entry.
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
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
Our EMC Laboratories are:
- ISO/IEC 17025-accredited (by UKAS, NVLAP, A2LA, or DAkkS)
- ISO 9001:2008-accredited
- A Notified Body for the European EMC Directive
- Approved Body for the UK EMC regulation
- Conformity Assessment Body for the FCC
