Mediana has over 30 years of expertise in manufacturing medical devices and a team of R&D specialists.
With 25 years of ODM partnerships with global companies, we have significant strengths
in
developing and manufacturing customized medical devices tailored to customers' needs.
Why MEDIANA
Medical device
company
30 years of
in-house technology
Medical device
R&D specialists
Supplied
medical devices to
80+ countries
Supplied medical devices to
2,500+ customers
ISO-certified
manufacturing facility
Certifications
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)
Process
MEDIANA Co., Ltd.
R&D Office : 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea
Seoul Office : 53, Donggwang-ro, Seocho-gu, Seoul , Korea
TEL : +82-033-742-5400 FAX : +82-033-752-5483
E-mail : info@mediana.co.kr
COPYRIGHT ⓒ 2024 MEDIANA Co., Ltd. ALL RIGHTS RESERVED.
