Announcement · Japan

Eclevar MedTech launches EU MDR compliance support for Japanese manufacturers.

Tokyo · Japan office

Eclevar MedTech has announced clinical trial services, using the Oracle Clinical One platform, to help Japanese medical device companies meet EU MDR 2017/745 compliance requirements.

EU MDR 2017/745JapanOracle Clinical One

ECLEVAR MEDTECH, a Paris-based global CRO, has announced that it will provide clinical trial services using the Oracle Clinical One platform to meet the needs of Japanese medical device companies. The company will initially focus on clinical trial support for the EU Medical Device Regulation (EU MDR) 2017/745, with plans to expand to other regions in the future.

Local support in Tokyo

To gain medical device approval, manufacturers must demonstrate conformity with all relevant aspects of the EU MDR. To help Japanese clients meet these requirements, ECLEVAR MEDTECH’s Japan office in Tokyo provides technology and local support from representatives experienced in clinical studies and regulatory affairs, backed by Japanese staff on Eclevar’s global team.

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