Certifications

Mediana is a leading medical device company in South korea. 

We develop and manufacture patient monitoring devices (PMD) and automated external defibrillators (AED), which we supply not only domestically but also to approximately 80 countries worldwide."
We are dedicated to the social value of saving lives and, with a strong sense of responsibility, are poised to lead a new era of 'AI healthcare.'

ISO13485 : 2016 / EN ISO13485 : 2016

Obtained in May 2020 (BSI)

CE Mark

Conformité Européenne: Certificate ensuring safety and quality management for the protection of European consumers and the environment

MDSAP ISO13485:2016

Certified under the Medical Device Single Audit Program for the United States, Australia, Canada, Brazil, and Japan

FDA : Food and Drug Administration

CB scheme certificate

 Certification of conformity to standards for electrical equipment (IECEE)

by the International Electrotechnical Commission

UL Certificate (NRTL)

Compliance with safety standards of the Nationally Recognized Testing Laboratory (NRTL)

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