BSI’s Overview of ISO 13485:2003, the Canadian Medical Devices Regulations, the European Medical Device Directives, and the Japanese Pharmaceutical Affairs Law course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly in the Canadian, European, and Japanese markets. Personnel responsible for quality systems for medical device manufacturers will benefit from this overview course which compares the management systems of these foreign regulations with the requirements of the quality management system outlined in ISO 13485. Students will gain knowledge of the requirements of the Canadian Medical Devices Regulations, the European Medical Device Directive, and the Japanese Pharmaceutical Affairs Law to provide leadership for their organizations when placing medical devices in foreign markets. An experienced instructor will lead participants through exercises and discussion points, including considerations in harmonizing these requirements and the Global Harmonization Task Force (GHTF) with respect to medical devices regulatory requirements.
Students receive comprehensive course manuals with reference materials.
General awareness of ISO 13485 and experience in a medical device manufacturing environment is recommended.
