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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.

 

EXPLORE

remote auditing
Stories

Remote auditing for critical medical devices

Ensure ongoing compliance with standard during the COVID-19 pandemic

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ISO 9001 & ISO 13485 – How Do These Standards Relate and Differ?
Report

ISO 9001 & ISO 13485 – How These Standards Relate and Differ

Discover the similarities and differences between the two standards

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EU MDR
Webinar

EU MDR and its impact on cardiovascular manufacturers

How to ensure a smooth transition to MDR certification.

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