Our team | i Access Consulting

TEAM MEMBER

i Access Consulting supports some of the most well-known brands and businesses around the globe, providing essential knowledge, discretion, and capability where and when our clients need it. Our work helps ensure proper certification and greater market access, the ability to meet product performance and quality metrics, and the promotion and elevation of a brand’s name and reputation. We provide the best value proposition for our clients. Our expertise includes the NMPA registration for medical devices, IVDs, and other life sciences products. We have over 20 years' experience advisers PhD and former NMPA/PMDA/Certification body' reviewer peer review the submission dossiers and provide the strategy for the regulatory pathway.

ELENA SU

Founder & President

Graduated from School of Economics and Management, Tohoku University, Japan. Have 17 years of professional experience in Regulatory Affairs in FUJIFILM Corporation and Notified body. Focus on multi-countries regulatory compliance, particularly in Japan, China, and the U.S. Have over 12 years membership at Japan Medical Device Industry Association and have been participating in joint-cooperation projects with Japan PMDA and the Ministry of Health, Labor and Welfare. Advisor of " Medical device international expansion program" of JETRO.

EJI OSHIDA

Advisor

Have over 30 years of professional experience in medical devices development and regulatory compliance especially for FDA, MDR and Japan Pharmaceutical in FUJIFILM Corporation and Sony Corporation. Conducted a number of presentations as a senior expert of the Notified body. Have contributed greatly to the development of medical device regulations in Japan through industrial association activities such as JIRA and the Japan Federation of Medical Devices Associations. Author of "Practice of Design and Development Processes and Pre-Market Approval for Medical Devices and Medical Device Software in Japan, the United States, and Europe."