Product Safety Testing 

Demonstrate that your active medical devices meet the globally recognised standards for Product Safety.

EMC Testing 

Test and certify that your active medical devices meet EMC requirements against the global IEC 60601 standards.

Radio/Wireless Testing 

Ensure the wireless performance of your medical devices meet global standards.

Mechanical & Climatic Environmental Simulation

We test your product to make sure it can operate in the harsh environments often required of medical devices.

Performance Testing 

Functionality, energy efficiency, durability and reliability testing for active medical devices.

Cybersecurity Testing

Ensure your medical devices meet the current and up-coming requirements for cybersecurity and ensure the security of patient information. 

Meet the demands of global markets

The market for medical devices is global, and in all important markets, regulatory requirements are in place to ensure that products meet the highest standards and do not present a risk to patients or users alike.

These regulatory requirements and approval methods differ between countries and only in a few cases are these mutually recognised.

For example, products must comply with EU Regulations in the European Economic Area, the requirements of the MHRA in the UK, the FDA’s requirements in the United States, Health Canada’s requirements in Canada, JPAL regulations in Japan and TGA requirements in Australia.

In addition to these markets, many important countries globally have their own regulatory systems for medical devices and managing these requirements is complex and time-consuming.

We provide a single point of contact for the testing and certification of your medical devices, allowing you to access your chosen markets quickly, easily and cost-effectively.

Product Safety Testing

We test your products against global standards including IEC 60601 to ensure your products are safe for use.

Safety testing for active medical devices based on the international IEC 60601 standards, including particular and collateral standards:

• IEC 60601-1:2005+AMD1:2012+AMD2:2020
• Risk Management files to ISO 14971
• EN/IEC 62304:2006+AMD1:2015 (Software life cycle processes)
• EN/IEC 62366-1:2015 (Usability of medical devices)
• AAMI ES 60601-1:2005/(R)2012 + A1:2012
• CAN/CSA C22.2 No. 60601-1:14
• Safety testing for in vitro diagnostic medical devices to IEC/EN 61010-1:2010+A1:2019+AC:2019
• EN/IEC 61010-2-101 and UL/CAN CSA 22.2 No. 61010-2-101
• IEC 60601-2-37 Ultrasonic medical diagnostic and monitoring equipment
• EN/IEC 60601-2-5 Theraputic Ultrasound & EN/IEC 60601-2-62 High-Intensity Focused Ultrasound (HIFU)    
• EN/IEC 62133:2012 safety testing of Lithium-Ion Batteries
• ANSI ISO 14708-3: 2017 for active implantable neurostimulators

EMC Testing

Ensure your products meet globally recognised standards for EMC for active medical devices, such as IEC 60601 and others, allowing you to access markets and deliver compliant products to your customers.

Medical EMC testing for active medical devices based on the international IEC 60601*1 standards family including, but not limited to:

• EN/IEC 60601-1-2:2015+A1:2020

Radio/Wireless Testing

Safe & reliable data communications is an essential part of a modern medical device. Our wireless testing ensures compliance with widely used protocols and services.

• WLAN, Bluetooth, ZigBee, GSM/GPRS, UMTS, Wireless Power Transfer (WPT), and LTE
• Ultra-low power active medical implants (ULP- AMI)
• Medical device RFID susceptibility testing
• Medical device wireless coexistence testing

Mechanical & Climatic Environmental Simulation

Ensure your product can operate now and into the future in the harsh environments found in medical applications with our extensive range of mechanical, climatic and environmental testing services.

• Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration etc

Performance Testing

Ensuring you can meet the performance goals for your product is key to market success. Our performance testing services allow you to exceed market demands and to demonstrate to your customers the quality of your product.

• Functionality, energy efficiency, durability and reliability, performance claims validation

Cybersecurity Testing

If you’re recording, storing or transmitting patient data, ensuring the security of that data is vital. Our Cybersecurity testing and certification services allow you to meet the cybersecurity demands of regulatory authorities and customers alike.

• EU MDR Annex I
• MDR and IVDR requirements MDCG 2019-16
• IEC 81001-5-1
• IEC 62304

Other related testing services

Alongside the services from Eurofins Electrical & Electronics, we can provide additional services from the laboratories and locations across the Eurofins network. Expand your testing and certification portfolio and grow your markets.

• Biocompatibility testing according to the ISO 10993 standards family and microbiological studies (GLP)
• Chemical characterisation for materials, extractable and leachable substances evaluation
• Medical device packaging testing with distribution simulation testing, fragility, shock compression testing

Global Reach with local contact

Our laboratories provide a single point of contact for manufacturers of active medical devices with access to all of the services available from our global network.

Extensive Capabilities 

Our testing laboratories provide extensive service capabilities for the testing of active medical devices, covering the globally recognised standards and testing requirements. 

Leverage the Eurofins global network

In addition to the testing services provided by our laboratories, we can leverage the world-leading capabilities of the Eurofins global network of laboratories, enhancing the services available to our customers.

Global Certification

Extend the market access of your active medical devices with our CB Scheme & NRTL Services.