Medical Device Development

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.

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

Program Benefits

• 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 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

Eligibility and Requirements

Apply to become a candidate for the program: A Declaration of Candidacy is required to establish candidacy in this program. Complete the application and pay the application and candidacy fee of $125 (non-refundable). Learn more about the benefits of becoming a candidate. Candidacy is not required to enroll into individual course in a program.

A candidate in the program is awarded a certificate upon the successful completion of 9 required units and 6 elective credit units totaling 15 units, each with a letter grade of “C” or better. All requirements must be completed within five (5) years after the student enrolls in their first course. To receive the Certified Digital Certificate after completing all the program requirements, students must submit the Request for Certificate to initiate the certificate audit process. Students not pursuing the certificate are welcome to take as many individual courses as they wish.

Note: Six credit units may be counted toward the Clinical Trials: Medical Device and Drug Development Certificate Program when courses are shared.

Discount

• Orange County Regulatory Affairs (OCRA) members save 10% on tuition. Email membership@ocra-online.org.
• San Diego Regulatory Affairs Network (SDRAN) members save 10% on tuition. Email membership@sdran.org.