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Medical Device Certification

Be confident of medical device market approval

Medical Device Certification

Be confident of medical device market approval

The global medical device market is governed by a broad range of national and international regulations and medical equipment certification standards. These regulatory requirements are complex and vary between regions, which can make it challenging to gain medical approval for your products in your target market.

TÜV SÜD has in-depth knowledge and experience of medical device certification standards around the globe and can provide advice and guidance to ensure you receive medical approval for your devices in key global markets.

For more information, read TÜV SÜD’s medical device market access guides via the links below.

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How to Prepare for TISAX Session 3
Webinar

June 23, 2020 - How to Prepare for TISAX: Session 3

We'll dive into using TISAX® with your supply chain, understanding the benefits of the Simplified Group Assessment

Register

EU MDR
Webinar

Impact of EU MDR on cardiovascular manufacturers

How to ensure a smooth transition to MDR certification.

Learn more

Cyber security of medical devices
Webinar

Cybersecurity of Medical Devices

Overview of currently available standards and guidance documents for cybersecurity.

Listen Now

Single Fault Safety Requirements in the MDR Webinar
Webinar

Single Fault Safety Requirements in the MDR

Learn the need and requirements for single fault safety

Learn More

Unmasking the Facts Webinar
Webinar

Unmasking the Facts

Protective equipment regulatory compliance

Learn More

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