Online Certificate in Medical Device Development
USA Online, USA
DURATION
9 up to 15 Months
LANGUAGES
English
PACE
Full time
APPLICATION DEADLINE
Request application deadline
EARLIEST START DATE
01 Jun 2025
TUITION FEES
USD 4,400
STUDY FORMAT
Distance Learning
Introduction
Emerging disruptive technologies, ever-changing regulations, and increased competition create many challenges for the medical device industry. This program provides comprehensive professional training in the successful research, conceptualization, development, and manufacturing of medical devices. Evaluated and developed in collaboration with governmental and industry advisors, this program meets the highest professional development standards for the medical device industry.
The updated curriculum addresses current industry trends and best practices in medical device design, development, and manufacturing. Coursework covers quality, safety, regulatory compliance, commercial and financial strategies, and post-market surveillance. Updated EU-MDR requirements are now included in the Regulatory Requirements for the Medical Devices course.
Ideal Students
Who Should Enroll
- Regulatory professionals, such as those in regulatory affairs or quality assurance
- Research, development, and engineering professionals involved in biomedical product design, development, validation, and manufacturing
- Manufacturing professionals
- Clinical managers and other healthcare professionals
- Field service engineers, commercial marketing and sales professionals
- Life science managers, such as research scientists and product managers
Admissions
Curriculum
Required Courses
- Regulatory Requirements for Medical Devices
- Medical Device Life-Cycle Management
- Medical Device Quality Systems
Elective Courses
- Medical Device Marketing
- Medical Device Manufacturing
- Medical Device Risk Management
Program Outcome
- Gain the knowledge needed to design, create and manufacture medical devices
- Acquire an understanding of the medical device product development process and expertise required to manage medical device intellectual property rights
- Learn how to implement successful design and manufacture of medical products by avoiding common quality and regulatory pitfalls
- Earn professional development credits to maintain your RAC credential with RAPS – Regulatory Affairs Professional Society
- Learn from seasoned instructors with practical industry experience
English Language Requirements
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