Purdue BME Offers New Certificate in Regulatory Affairs and Regulatory Science for Medical Devices
Purdue University has launched a new graduate-level certificate in Regulatory Affairs and Regulatory Science for Medical Devices to help meet this growing need. The program offers a unique training opportunity to prepare students for rewarding careers in the medical device industry. Success in industry requires knowledge across multiple areas covering the life cycle of a product, including medical device development, laboratory and clinical testing, quality systems, and regulatory submission and approval processes. Understanding and practical application of these critically important topics, and others, can be gained through courses offered as part of the certificate.
The new certificate offered by the Weldon School of Biomedical Engineering at Purdue will prepare new regulatory professionals to meet current industry needs. Courses are taught by expert Purdue faculty and through strong partnerships with content experts from the medical device industry and regulatory agencies. During the past year we have engaged with over 50 experts from across the medical device industry, regulatory agencies such as the United States Food and Drug Administration, and practicing clinicians, spanning globally from Europe to America to Asia, who have generously shared their expertise and diverse real-world experiences to help develop relevant and practical course content and teach concepts that they live daily in their careers. This practical approach has resonated with students and offers ongoing opportunities for career development and to build mentoring relationships.” – Professor Aaron Lottes, Director of the Graduate Certificate
To earn the certificate, students take three biomedical engineering courses totaling 9 credit hours, including at least two of the three available regulatory courses plus a selective course in engineering ethics, biostatistics or a third regulatory course; students can choose their selective course based on their own individual interests and career goals. Courses are open to biomedical engineers as well as other engineering and health-related disciplines. he certificate can be completed on-campus, or 100% on-line from anywhere in the world, or as a hybrid approach, thus increasing accessibility to a diverse group of current and prospective students including working professionals.
The thriving medical products industry in Indiana and the Midwest region has positioned Purdue University as a leader in regulatory education and helps meet a critical training need for the medical device industry. This new regulatory certificate is an important component to help differentiate students as they prepare for positions in industry and help those already in industry advance their careers. Additionally, the 9 credit hours required to earn the graduate certificate may be applied to Purdue's Master of Science in Biomedical Engineering degree, including a new 100% online option, if a student decides to continue and pursue a master's degree.
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