Program Overview

Regulatory Affairs and Regulatory Science for Medical Devices Program

Overview

The Regulatory Affairs and Regulatory Science for Medical Devices program is 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.

Curriculum

The program requires nine credits in regulatory and regulatory-related courses, all of which 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 Courses

• Two of the following three regulatory courses:
  • BME 56100: Preclinical and Clinical Study Design
  • BME 56200: Regulatory Issues Surrounding Approval of Biomedical Devices
  • BME 56300: Quality Systems for Regulatory Compliance

Elective Courses

• One elective course from the following:
  • 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 *Note: Regulatory courses used for the required section will not be allowed to be utilized in the elective section.

Admissions

To be eligible for the program, students must hold a bachelor's degree in an appropriate area (Engineering, Science, Mathematics, or Technology) or be pursuing a current graduate degree at Purdue University in a STEM field with a minimum GPA of 3.0.

Program Details

The program is designed to provide students with a comprehensive understanding of regulatory affairs and regulatory science for medical devices. The curriculum is structured to ensure that students gain practical knowledge and skills in regulatory quality, science, and compliance, preparing them for careers in regulatory teams in the medical device industry.