Testing of Active Medical Devices and IVD equipment

What is active medical devices and ivd equipment testing?

Most active medical devices and IVD equipment use electricity as their source of energy. Consequently, the inclusion of hardware elements, software and mechanical issues within the device must comply with broader testing and regulatory requirements. Testing of active medical devices and active implantable medical devices (AIMD) involves putting a product through a rigorous series of tests which reveal potential hazards and design faults. Testing also provides evidence of compliance with relevant regulations.

Why is it important to carry out testing on active medical devices and IVD equipment?

Testing active medical devices and active implantable devices is essential for several key reasons:

• Demonstrate compliance with relevant regulations in your target market
• Testing reveals design faults and hazards early in the product life-cycle
• Ensure complete safety for medical staff and patients when using devices
• Avoid reputational damage and civil litigation should a device be shown to be faulty

TÜV SÜD is your one-stop testing house for active medical devices and ivd equipment

TÜV SÜD has extensive experience testing active medical devices and active implantable devices and is recognised around the world as a leader in the field. We offer a broad range of testing services including Electromagnetic Compatibility (EMC) & Radio Equipment testing, electrical safety testing and environmental testing. These can be combined with specialised testing services such as software security testing and usability evaluations under real life test conditions. We also have an accredited Ultrasound Lab and a special lab for Rehabilitation Devices.

Our highly-skilled engineers are able to conduct extensive tests in our state-of-the-art laboratories to put your active medical device through its paces. And we stay up to date with all the latest laws and regulations to ensure your product is compliant.

TÜV SÜD’s active medical device and ivd equipment testing services

Our functional safety experts can conduct tests to identify potential hazards from electrical, mechanical or design faults that may occur during device usage. The service includes:

• Comprehensive requirements gathering
• Extensive tests at our state of the art laboratories
• Analysis, reporting and recommendations

We understand that time to market is a key consideration when choosing a testing house, and so TÜV SÜD offers expedited testing programs. Please contact us to learn more.