Medical devices are essential in healthcare, and their development, approval, and use are subject to regulatory requirements. This course provides a detailed overview of the regulatory framework for medical devices and related clinical research activities. Students will gain an understanding of the concepts such as medical devices and their regulation, medical device classification and risk assessment, regulatory submissions for medical devices, and pharmacovigilance and safety monitoring.
Upon completion of this course, students will be able to apply their knowledge to evaluate the risks and benefits of medical devices, design and conduct clinical research studies, and communicate findings to regulatory authorities and healthcare professionals. This course is ideal for individuals who are interested in pursuing a career in medical device development, clinical research, or regulatory affairs.