Regulatory Affairs for Medical Devices

Emphasis on Regulatory Affairs for Medical Devices

Students enrolled in any of the graduate programs offered by the Weldon School of Biomedical Engineering can participate in a sequence of courses designed to educate participants on practical regulatory affairs at both the initial approval and later compliance stages. Students gain valuable in-depth knowledge of regulatory requirements as well as guided practice with effective regulatory document submissions. This advanced education in quality and regulatory compliance will prepare students for rapid integration into regulatory affairs teams in critical areas of the industry.

Preclinical and Clinical Study Design

(This course helps students understand the practical and ethical issues surrounding how a device can be tested in animal models and in human clinical trials and how the two types of studies are integrated and implemented.) Topics Covered: Overview of Medical Device Development; Ethics Concerns in Animal and Human Trials; Pre-Clinical Evaluation Strategies for Orthopedic, Neurologic, and Cardiovascular Medical Devices; Experimental Design; Issues in Managing or Overseeing Human Clinical Trials; Integration of Studies for Regulatory Approval.

Regulatory Issues Surrounding Approval of Biomedical Devices

(This course helps students understand the regulatory approval processes in both the US and other countries for various types of medical devices.) Topics Covered: Course Introduction; classification overview; 510(k) regulations and process; letter to file; special submissions; PMA regulations, content, strategies, and processes; labeling and claim language; supplementals and annual reports; combination devices; HDE, HUD, and pediatric approvals, STED and CER.

Regulatory Compliance for Biomedical Devices

(This course helps students understand the regulatory environment of manufacturing and marketing of medical devices.) Topics Covered: History of regulation and overview of regulatory affairs; regulatory agencies and oversight; regulatory differences between devices, drugs, biologics, and combination products; current US and EU device regulations and device standards for quality control, quality assurance, and regulatory compliance; purpose and preparation of major documents in regulatory affairs.

Courses can be taken in any order. Please contact the BME Graduate Office if you are interested in enrolling in these courses.