Regulatory Affairs and Regulatory Science for Medical Devices (On Campus/Residential)
Students enrolled in this certificate program will 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 regulatory quality, science, and compliance will prepare students for rapid integration into regulatory teams in critical areas of medical device and other related industries.
Nine credits in regulatory and regulatory related courses) are required for completion of the certificate. All courses must be earned through Purdue West Lafayette.
An average grade of B or higher in the two core courses and an average of 3.0 or higher overall are required.
Required: Two of the Following Three Regulatory Courses
The student will choose two of the three regulatory courses listed below. You are allowed to take the third course as an elective if you would like to take all three.
- BME 56100: Preclinical and Clinical Study Design
- BME 56200: Regulatory Issues Surrounding Approval of Biomedical Devices
- BME 56300 Quality Systems for Regulatory Compliance
Choose: One Elective from the Following
The student must choose one elective course from those listed below. Student must pick an elective that was not used in the required section.
- BME 50100: Biostatistics
- BME 56100: Preclinical and Clinical Study Design*
- BME 56200: Regulatory Issues Surrounding Approval of Biomedical Devices*
- BME 56300: Quality Systems for Regulatory Compliance*
- BME 56400: Ethical Engineering of Medical Tech
*Regulatory courses used for the required section will not be allowed to be utilized in the elective section.
Student must hold a bachelor's degree in an appropriate area (Engineering, Science, Mathematics, or Technology) or pursuing a current graduate degree at Purdue University in a STEM field with a minimum GPA of 3.0.
How to Apply
If you are considering applying to our Graduate Certificate program, please visit our How to Apply page.