Grad Course Series and Grad Certificate in Regulatory Affairs for Medical Devices
On Campus Regulatory Certifiate
The Weldon School of Biomedical Engineering offers a variety of courses designed to educate participants on practical regulatory affairs at the initial approval, the preclinical strategy and clinical strategy phase, and later, the manufacturing compliance stage.
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 prepares students for rapid integration into regulatory affairs teams or in critical areas of the industry in general as you understand the language and needs of a highly regulated field.
BME 56100 Preclinical and Clinical Study Design
Medical device companies, and the engineers they employ, have an ethical and legal responsibility to robustly examine device safety and performance. This course covers the responsible conduct of preclinical and clinical study research necessary for obtaining marketing approval. Hear first-hand experiences of industry experts and gain insights about the testing processes for obtaining FDA and global marketing approvals for medical devices. Topics will include device development and design, bench and animal testing (e.g., including standards and guidances, statistics, test development, study design, test protocols and reports, types of bench tests, biocompatibility testing, large animal studies), and clinical study design and testing (e.g., including clinical study strategy, clinical study design, clinical statistics, clinical study protocols, real-world evidence, early feasibility studies, patient preference, post-market surveillance, clinical data strategy).
(Course typically offered in the Fall Semester as an on-campus section in West Lafayette, and a distance section through Engineering Online.)
BME 56200 Regulatory Issues Surrounding Approval of Biomedical Devices
Learn about the processes for obtaining FDA and global marketing approval or clearance for biomedical devices. Prior to marketing a medical device, a governmental approval or clearance is required depending on the type of device and the risk associated with the device. This course focuses on regulatory processes for Class II and III devices in the US, including combination devices. There is a specific focus on 510(k) and PMA requirements. We will also briefly cover regulatory requirements for medical devices in the European Union, Japan, and China. Throughout the course, emphasis will be placed on regulatory science, regulatory strategy and principles of interacting with regulatory agencies. Not only will you learn from industry experts and FDA representatives, but you will also have opportunity to practice. Students form small teams for making a mock FDA meeting presentation.
(Course typically offered in the Spring Semester as an on-campus section in West Lafayette, and a distance section through Engineering Online.)
BME 56300 Quality Systems for Regulatory Compliance
An introduction, overview, and systematic study of the quality system requirements governing the development, manufacturing, distribution, and marketing of medical devices is at the core of this class. Spend time learning about and discussing the ISO 13485 and 21 CFR Part 820 Quality System requirements for the US and global markets. Focus is on understanding the critical elements of regulatory science and quality compliance from a design control perspective. Instruction in regulatory science and a range of perspectives on quality is provided by a variety of presentations from industry representatives and FDA.
(Course typically offered in the Summer Semester online and potentially as a hybrid course through Engineering Online.