Elevate your medical device testing to global standards
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.
Testing active medical devices and active implantable devices is essential for several key reasons:
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.
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:
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.
Fulfill requirements of Annex I to the MDR
Explore economic operator requirements
Learn the classification rules introduced by the European In Vitro Regulation EU 2017/746
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Bosnia and Herzegovina