Element is the perfect partner for EMC testing, certification and global approvals of your Class I, II, and III electronic medical devices.
Element works with manufacturers of electrical medical devices to identify the testing, certification, and evaluation needed for compliance to electromagnetic safety standards and international regulations. Our medical device EMC services include rigorous testing to international standard IEC 60601-1-2 to ensure adequate electromagnetic safety, performance and effectiveness of your medical devices and equipment for a quick global market access.
Our EMC laboratories in the US and UK hold a range of accreditations and approvals including ISO/IEC 17025:2005 from NVLAP, A2LA or UKAS, 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.
Our Medical Device 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
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 essential performance and basic safety. Element has developed a range of test suites to help and test these aspects.
Harmonised standards for medical devices
- EN/IEC 60601 series
- ANSI C63.27 on wireless coexistence
- AIM 7351731 on RFID assessments
- US 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, Element 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, our medical regulatory affairs experts work with you to identify the appropriate requirements for your specific medical device. This helps to remove 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.
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.
More from Element
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.
Local laboratories, global platform
Doing business with one of our laboratories enables our clients' access to our global platform of expertise, capacity and capabilities.
CE Marking and Testing
CE marking is a mandatory conformity mark enabling you to enjoy free movement between all 28 Member states.
Find out how Element’s experts helps its customers to bring a diverse range of electronic, wireless, medical and consumer products to a worldwide audience.