Makoto Washinosu
Chief Executive Officer
Profile
Extensive experience in organizational management and human resource development as a leader with expertise in product quality assurance, quality management systems, and regulatory compliance for medical devices
1992 Kodak Japan Ltd.
Assigned to the medical device products division. Engaged in area sales and sales promotion, product technical support, and Japan quality (worked at the Oregon plant in the U.S.).
2005 Johnson & Johnson, K.K.
As a manager of a quality assurance organization, was involved in quality management system (QMS) operation, organization building, and human resource development. Was certified as an ISO13485 internal auditor for quality management systems and had extensive experience in QMS audits of domestic business units and QMS audits of foreign manufactures as a lead auditor for QMS internal audits. As a subject matter expert (SME) in domestic medical device regulatory inspections conducted by the Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency, and the Pharmaceutical Affairs Division of prefectural governments, managed many external audits and was familiar with the procedures for handling external audits.
2020 Sakura Global Holding Co., Ltd.
Led several gap improvement projects based on QMS by ISO13485 for QMS ordinances for medical devices and in vitro diagnostis, US FDA medical device regulations, European in vitro diagnostic regulations, etc.
2023
Started an own business as an expert and consultant to help and collaborate with many companies to solve their business issues regarding the establishment of QMS, which is a legal requirement for manufacturing and marketing medical device products. Established Strategy in Motion Co., Ltd. in Mar. 2023.
Kazuyuki Kashikie
Senior Managing Director
Profile
Extensive experience related to regulatory strategy, quality assurance and safety based on experience in R&D, technology development and regulatory procedures in medical device companies
1989 Terumo Corporation
Belonged to the Material Development Division of the Research and Development Headquarters and the Development Section of the Ataka Plant. Engaged in research and development of hollow fiber membranes used in artificial kidneys and lungs, and flat membranes used in blood filters. In the commercialization of dialysis membranes (dialyzer) for artificial kidneys, was in charge of a series of development work including prototyping, verification, patent application, and transfer of production.
2005 Boston Scientific Japan K.K.
Belonged to the Safety Management Department. Responsible for investigating and collecting data from manufacturers and design/developers in Ireland and the U.S. regarding products and new products that have failed. Engaged in safety management operations such as reporting the results of investigations to the PMDA.
2006 Johnson & Johnson, Inc.
Belonged to the Regulatory Affairs Department. Was in charge of sterilizers and endoscopic procedure-related products and is involved in application, notification, response to QMS conformity surveys, change management, support for new product development, and organization of in-house training programs.
2017 ORT Medical, Inc.
Was in charge of regulatory procedures for angiography-related products. Had also served as a Responsible Engineer and General Manager of Marketing authorization holder license.
2019 Sakura Seiki Co.
Concurrently worked in the Infection Control Division's Marketing/Product Development Department and Quality Assurance Department. In the Product Development Department, was in charge of projects to develop new and improved sterilization equipment. Was also involved in supporting the development of laboratory equipment products. In the Quality Assurance Department, engaged in activities such as CAPA and internal audits in the operation of the quality control system.
Year 2023
Participated in the establishment of Strategy in Motion Co., Ltd.