The Research & Consulting Division of SunFlare Co., Ltd. delivered a lecture entitled "Basic Introduction to Quality Management Systems" at the 2nd Hiroshima Medical-Industrial Cooperation Salon. The event was hosted by the Workshop for Medical-related Industry of Hiroshima (Hiroshima Industrial Promotion Organization in the Hiroshima Medical-Industrial Cooperation Promotion Center) on Tuesday, August 7, 2018. The lecture was attended by representatives from a variety of companies based in Hiroshima prefecture that are engaged in the development of businesses related to the supply of device components or the provision of contract manufacturing services for medical devices.

Event details
Venue: Revenue Office building of the Hiroshima Prefectural Government
(10-23 Motomachi, Naka Ward, Hiroshima City, Hiroshima Prefecture)
Date and time: 15:00 to 17:00 on August 7, 2018
Lecturer: Yuki Kurokawa, Consultant, Research & Consulting Division, SunFlare Co., Ltd.

Program
Title: Basic Introduction to Quality Management Systems
Overview: The lecture covered key elements of the theory and practice of quality management systems (QMS) that must be understood by companies engaged in the supply of components or the provision of contract manufacturing services for medical devices. It also addressed matters such as the strategic utilization of a QMS and various quality assurance certification systems (e.g., ISO).
・Company profile
・Classification of health care products using examples
・Basic issues related to regulatory compliance for medical devices
・Overview of the QMS Ministerial Ordinance and ISO 13485
・Practical steps for the acquisition of ISO 13485 certification

Website of the Workshop for Medical-related Industry of Hiroshima: http://www.hiwave.or.jp/ikourenkei/