Mediana Certifications

ISO13485:2003 / EN ISO13485:2012/ CE Mark

Obtained from DNV(Det Norske Veritas),NSA(National Standard Authority of lreland)in June2000.

EN ISO13485:2012

International certificate on quality guaranty relating to design, development,production,
installment and calue-added services.

CE Mark

a quality management certificate that assures safety to European consumers and environmental protection.

CMDCAS ISO13485:2003

a quality management certificate of Canada(NSAI).

FDA : Food and Drug Administration

FDA 510(k) cleared
GMP(Good Manufacturing Practice) compliance

CB scheme certificate

CB Scheme, established by the International Electrotechnical Committee for Conformity Testing to Standards for Electrical Equipment (IECEE),provides a means for the mutual acceptance of test reports among participating safety certification organizations.

UL certificate (NRTL)

UL certification derives from Underwriter’s Laboratory, an organization that tests and certifies electrical devices and appliances for consumer safety.
UL is recognized by Nationally Recognized Testing Laboratory(NRTL), which determines that specific equipment and materials ("products") meet consensus-based standards of safety to provide the assurance, required by OSHA in U.S.