Currently, specialized knowledge and procedure are required for Application for approval since safety and efficacy of medical device, quality control and safety measure conducted by manufacturing and sales company are severely evaluated.
Especially in Specially controlled medical devices, clinical trials based on scientific and ethical validity, and obtaining an information related to safety and effectiveness through the post-marketing surveillance are required.
In EP Mediate, our team with deep expertise in medical device fully support your business including regulatory affairs, clinical trials, and post marketing surveillance.

• Medical Device Development Department
• Medical Device Regulatory Affairs Department

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Since Ethical Guidelines for Medical and Biological Research Involving Human Subjects was issued in April 2015, ethical considerations and ensuring reliability have been more important at human clinical trials.
The human clinical trials must be conducted to evaluate the safety and efficacy of food product to apply for TOKUHO, which is a label for foods for specified health use. Also, we need to submit systematic literature reviews or to do clinical studies to verify the scientific evidence of safety, functionality, and effectiveness of the system of “Foods with Functional Claims.“ If there is no evidence for the system of the foods, a cease and desist order will be received from Consumer Affairs Agency for abuse of Act against Unjustifiable Premiums and Misleading Representations.
EP Mediate establishes the system for studies corresponding with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects , and keeps in mind to provide highly reliable data.

• Study Commissioned Business
• Study Support Business
• Clinical Study Site Support Business

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We provide sufficient support to promptly conduct clinical study at affordable costs via one-stop solution. Based on tangible scenario, this one-stop solution makes it possible to launch IVD candidates developed in research activities from academia and/or companies.

• Seeds Assessment of IVD
• Support for Clinical Study
• Support for Advanced Medical
• Support for Regulatory Affairs Support

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