Regulatory Affairs in Medical Engineering is a specialized course designed to equip professionals with the essential knowledge and skills required to navigate the complex regulatory landscape of medical devices. The curriculum emphasizes practical applications and project-based learning, allowing participants to engage with real-world scenarios and develop solutions that meet current regulatory standards. This course not only prepares graduates for immediate employment opportunities but also enhances the capabilities of business professionals seeking to advance their careers in the healthcare sector.
Participants will explore a range of topics that cover the lifecycle of medical devices from conception to market entry. The course includes interactive sessions where learners will collaborate on projects, culminating in a final project that focuses on a specific regulatory challenge within the medical engineering field. By encouraging participants to publish their findings in Cademix Magazine, the program fosters a culture of knowledge sharing and professional development.
Overview of Regulatory Frameworks for Medical Devices
Key Regulatory Agencies and Their Roles
Understanding Pre-Market and Post-Market Requirements
Risk Management Principles in Medical Device Development
Clinical Evaluation and Investigation Processes
Quality Management Systems (QMS) and ISO Standards
Labeling and Advertising Regulations for Medical Devices
International Regulatory Trends and Harmonization Efforts
Strategies for Successful Regulatory Submissions
Final Project: Developing a Regulatory Strategy for a New Medical Device