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