Kenji Yashiro, Senior Consultant, Japanese Regulatory Affairs

With a background in engineering and experience in medical device distribution, Kenji Yashiro has been exposed to many facets of the medical device manufacturing and sales process, from device conception to final distribution to the end user. He uses this experience for the benefit of Emergo clients wishing to enter the Japanese market. Based in Emergo's office in Tokyo, Mr. Yashiro spent nearly two years with KPMG's medical device consulting division in Tokyo. His prior experience as a design, process and quality engineer at one of Japan's most respected manufacturers of sterile needles and catheters gave him an in-depth understanding of the manufacturing and quality control process.  He also spent time working for a medical device distributor specialzing in respiratory, digestive surgery and fertility treatment products. In his role as a Senior Consultant with Emergo Japan, Mr. Yashiro assists clients with Japanese Pre-Market Application (PMA) preparation and other quality assurance and regulatory issues.