Medical Device and IVD Equipment Testing

Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product

Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product

Comply with Regulations and Standards

At TÜV SÜD, we combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing you with a one-stop solution. Our testing puts your product through a comprehensive medical device industry assessment, and helps you demonstrate compliance with standards and regulations around the world.

Our tests cover your full design and production cycle - from prototype testing to CB certification and lab tests for ergonomics, electrical, mechanical and functional safety assessments, as well as software testing. We also conduct inspections of production facilities, environmental monitoring, and pre-shipment inspections, as well as testing for both active medical devices and IVD equipment and non-active medical devices.

Our Medical Device Testing Services

 

EXPLORE

Establishing an EMC Test Plan for Medical Devices According to IEC 60601-1-2 4.1
White paper

Establishing an EMC Test Plan for Medical Devices According to IEC 60601-1-2 4.1

Learn the most significant changes to IEC 60601-1-2

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One-Stop Shop for Medical Device Testing
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One-Stop Shop for Medical Device Testing

Minimize product risks with medical device testing

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iso 10993 webinar series
Webinar

ISO 10993 Webinar Series

A webinar series aiming to provide attendees with strategic insights into the latest ISO 10993 framework.

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IEC 81001-5-1 cybersecurity for medical device
White paper

IEC 81001-5-1 for Medical Device Cybersecurity

Understand the requirements of IEC 81001-5-1 standard

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