BS4206 MEDICAL DEVICE RELATED REQUIREMENTS & REGULATIONS

This course aims to provide participants with a comprehensive understanding of the regulatory requirements and quality management systems (QMS) necessary for the development, manufacturing, and distribution of medical devices. Through a series of interactive sessions, participants will gain insights into key standards, regulations, and best practices governing the medical device industry, enabling them to navigate the complex landscape effectively. This course covers essential topics in the medical device industry, starting with defining medical devices and stakeholder roles according to ISO 13485:2016. Students will explore ISO 13485 requirements and their relevance to different industry entities. The course also focuses on risk management, process validation, and global regulations such as the Health Products Act in Singapore, EU Medical Device Regulation, and the Quality System Regulation in the USA. Additionally, participants will learn about ISO 14971:2019 for risk management and the importance of process validation for product quality and safety. The course concludes with an overview of the Medical Device Single Audit Program (MDSAP) and its benefits, along with insights into compliance requirements. Through a mix of theoretical learning, case studies, and interactive discussions, students will gain practical tools to navigate regulatory challenges effectively and ensure compliance in the medical device industry. At the end of this course, students should have a clear understanding of medical device regulations and able to apply these requirements in product development. Students will be required to perform casework to test the ability to apply these concepts in real scenarios. An international recognized certificate will be issued to students fulfilled with requirements.