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.