About us

Mission

As the gateway into Japan PMDA and China NMPA regulations for medical devices and IVD products, we are committed to your needs.

Mission

At i Access Consulting, we recognize the importance of compliance with regulatory requirements to ensure patient safety and facilitate market access. Our team of highly knowledgeable professionals is well-versed in the intricacies of medical device regulations in Japan and China. We stay up-to-date with the ever-evolving regulatory environment, keeping track of the latest guidelines, standards, and procedures to provide you with accurate and timely advice..

With our expertise and deep understanding of the regulatory frameworks in Japan and China, we are dedicated to providing comprehensive consulting services on medical device manufacturing process controls, QMS management, regulatory strategy, dossier preparation, on-site seminars, and technical support to help you bring your innovative medical devices to market seamlessly.

Our Vission

・We aim to efficiently and effectively provide specialized consulting and application support services for medical devices, while assisting medical device manufacturers in overcoming challenges and continuously practicing innovation ourselves. Our goal is to deliver high-quality consulting services.

・We strive every day to contribute even a little to our customers' well-being and growth, and to get closer to becoming a company that contributes to the development of society.

Our Team

The founder and president of our company has over 15 years of professional experience in Regulatory Affairs in one of a top 10 medical device industry and the biggest Notified body. She is the member of Japan Medical Device Industry Association and has been participating in joint-cooperation projects with PMDA and the Ministry of Health, Labour and Welfare.

The registration team includes a Ph.D. from Kyoto University, a senior regulatory expert who has worked in a fortune 500 medical device company, and a senior consultant who has worked for a Notified body as a reviewer for Japan registration and QMS auditor. Our experts for China registrations have the experience in China NMPA testing center.

MEDICAL DEVICE REGULATION SEMINAR