Announcement of our new consulting service for Quality Assurance and Regulatory Affairs and new members joining our team.

We are pleased to announce that our company has started providing consulting services for Quality Assurance and Regulatory Affairs in order to meet the increasing demands of the rapidly growing global medical device industry.

In recent years, the global medical device industry has been expanding with a growth rate of 3-5%, and in Japan a number of companies in other industries are entering into the medical device market, leading this to become one of the most remarkable markets. Despite its growth, due to the Pharmaceutical Affairs Act update this November, a dearth of human resources in quality assurance and regulatory affairs, and an increasing number of global clinical studies, there is a call for skilled professionals to establish an operating corporate governance to ensure quality and to build a regulatory strategy.

Given these market circumstances, we have commenced providing consulting services for Quality Assurance and Regulatory Assurance in order to accelerate our seed-sourcing activities and fill the significant gap in experience and human resources in this growing market. As our first project, we are providing this service for the global clinical study of Class IV medical devices.

The founder of our company, Takahiro Uchida, is uniquely qualified to lead us in this arena , as he has significant experience as a medical device reviewer for the U.S. Food and Drug Administration, leveraging his personal human network and insight as a bridge between Japan and the United States.

In addition, we are delighted to welcome our new Director for Quality Assurance and Regulatory Assurance, Tetsuo Murakami, who has been working as a specialist for QA/RA in the medical device industry, and our Medical Director, Hiroaki Kobayashi, who has a wide range of experience in areas ranging from clinical physician to patent associate.
>> Link to the profiles of team members

JOMDD will continue to commercialize Japanese medical innovations and medical device seeds with our growing incubation capabilities through our new competitive advantage of quality assurance and regulatory affairs.