Systematic Literature Review and Medical Regulatory Writing

3 units

Medical devices are critical for patient care and public health, so companies must comply with extensive regulations to ensure the safety, efficacy, and performance of these devices. Medical device companies are expected to demonstrate that their devices perform as intended using data from well-designed clinical trials and “real-world evidence.” Given the expense of conducting clinical trials, real-world evidence is increasingly important for companies seeking to demonstrate the safety and performance of their medical device. This course, Systematic Literature Review and Medical Regulatory Writing, is designed to equip students with the necessary skills to conduct comprehensive literature reviews and produce high-quality summary reports of the state-of-the-art for medical devices. This course is ideal for individuals pursuing careers in medical research, clinical trials, medical regulatory writing, and related fields. It is recommended that students have a background in medical sciences or a related field, basic understanding of research methodologies, and a desire to gain proficiency in academic writing.