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The regulatory environment for medical devices is designed to balance the need for innovation while ensuring patient safety. Compliance with these regulations requires a thorough understanding of the specific requirements of each market, and diligent adherence to quality standards. As technology advances, regulatory frameworks continue to evolve, necessitating adaptability from manufacturers. This project provides a comprehensive understanding of the regulatory environment governing medical devices.
In this Build Project, you'll step into the role of a Regulatory Affairs Specialist and tackle the challenge of navigating the complex and variable regulations governing medical devices. Working under the guidance of an experienced industry expert, you'll develop a regulatory strategy document that addresses the nuances of regulations across different countries. Through this project, you'll become proficient in interpreting guidelines and ensuring compliance, gaining valuable skills essential for success in the medical device industry. You'll also gain insights into maintaining consistent adherence to quality management systems, a crucial aspect of any medical device company's operations.
Get to know the Project Leader and other students, ask questions about the project requirements, prepare your workspace.
Students will get to know about the US regulatory requirements for medical devices and how they came into being.
Students will get to know about the EU regulatory requirements for medical devices and what role different bodies play.
Students will be able to understand how regulatory strategy is determined based on the regulatory pathway.
Students will understand the significance of Quality Management System for a medical device company.
Advertising and Promotion may not sound very important, but they do play a significant role in healthcare that students will learn about.
The world is going digital and so is healthcare technology. Students will learn how FDA governs Software as Medical Devices.
Polish your project deliverables and present them to the Project Leader and other students in the final group session.
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Hiral Vora is a Regulatory Affairs Fellow at Open Avenues Foundation, where she works with students leading projects in the Regulatory Field.
Hiral is a Lead Quality and Regulatory Affairs Specialist at Elucid Bioimaging, Inc. where she works on medical device submissions and ensuring compliance with the regulations.
Hiral has 4.5 years of experience as a regulatory specialist. Throughout her experience, she has participated in many audits for the company and communicated with regulatory authorities on various occasions.
She holds a degree in Regulatory Affairs.
A fun fact about Hiral: Her go-to comfort binge watch TV show is F.R.I.E.N.D.S and she has seen the entire series more than 7 times.