Medical Device Management and Regulation, Certificate
Program Details
- Location
- Akron Campus
- Level
- undergraduate
- Degree/Program Type
- Certificate Program / certificate
- Format
- In-person
- Course Info
- Curriculum Guide
- College
- College of Engineering and Polymer Science
- School/Department
- Department of Biomedical Engineering
Program Contact
- Dean's Office: College of Engineering and Polymer Science
-
Auburn Science and Engineering Center
330-972-6978
Overview
The 15-credit Certificate in Medical Device Management and Regulation prepares students for careers in the rapidly growing medical device industry. This program provides students with an opportunity to develop and document their understanding of medical devices, their design and role in healthcare, and the regulatory processes that govern their development, manufacturing and approval.
Students gain knowledge of the regulatory frameworks used to ensure medical devices are safe and effective, including standards from the U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), and the European Union. Coursework also explores risk management, good manufacturing practices, quality systems, and the regulatory pathway for bringing new medical technologies to market. In combination with an engineering degree, this certificate helps prepare graduates for professional practice in biomedical engineering and the medical device industry.
Admissions Requirements
Students who meet The University of Akron’s admission requirements and choose engineering as their major are directly admitted into the College
If you're coming from high school, your high school records will help determine the best first-semester courses for you
The Certificate in Medical Device Management and Regulation is open to all undergraduate students in Biomedical Engineering; to Juniors in good academic standing enrolled in other engineering programs.
Career Outcomes
Graduates of the Certificate in Medical Device Management and Regulation are prepared for careers supporting the development, manufacturing and regulatory approval of medical technologies. The program provides knowledge of regulatory standards, quality systems and risk management used throughout the medical device lifecycle. With these skills, graduates can pursue opportunities in medical device companies, biomedical technology firms, healthcare systems, regulatory agencies and research organizations, supporting roles in regulatory affairs, quality assurance, product development and medical device manufacturing.
YES, some things just set us apart.
Customize Your Coursework
Match your career interests, including specialized paths like prosthetic design
Research Experience
Gain hands-on research experience and present your work to faculty, industry professionals and at conferences
Senior Capstone Projects
Work with clinicians, surgeons or caregivers on senior capstone projects that solve real-world healthcare challenges while building a strong sense of community through student organizations
Engineering Excellence since 1913.
We’ve been reaching new heights for more than a century — and we’re not slowing down.
Learn Through Experience
Our engineering students learn through experience. Our famed co-op program, one of the oldest in the country, provides students with paid industry experience. On average, students earn $47K over three co-op rotations, all while completing their degree. Within six months of graduation, our 2024 College graduates launched careers, pursued graduate school, or entered military service, with an average starting salary of $72K.
Undergraduate Research
Undergraduate research opportunities and senior capstone projects empower students to innovate, apply classroom knowledge, and strengthen collaboration skills in professional settings.
Exceptional Education
We offer an exceptional education. Our expert professors are not only leaders in their fields but are also deeply committed to your success. They are passionate about helping you achieve great things and are dedicated to supporting every student's journey in engineering.
Design Teams & Student Organizations
Build medical devices, robots, race cars, rockets and more on our design teams, which rank among the best in the nation and world in competition. Students can also join one of our many student organizations such as Biomedical Engineering Society, Society of Women Engineers, and Medical Device Design Team.
“I chose UA because of their amazing Biomedical program — with hands-on experiences, supportive faculty, and high-quality lab spaces.”
“In high school, I wanted to combine two things that I loved the most to choose my major and career, which included helping others and the love for creating and improving things. What be er way to incorporate these things than through Biomedical Engineering, which would give me the opportunity to create products to save and improve lives.”
“It is my dream to help people live happier and more fulfilling lives. I hope to improve the medical resources available to others, especially for the elderly – they hold a special place in my heart.”
“Engineering experiences teach us that problems are opportunities in disguise. By approaching these challenges with creativity, critical thinking, and determination, we can not only overcome obstacles but also create innovative solutions that drive progress and success.”
