Regulatory Obligations for a New Medical Product
Regulatory Affairs is a professional field that uses scientific knowledge, federal legislative compliance requirements, negotiation skills, business intelligence, and current regulatory knowledge to strategize, submit, and negotiate a therapeutic product or medical technology’s regulatory pathway with a federal regulatory agency for its market approval. BU offers one-on-one consultation with Anu Gaur, PhD, to help researchers and practitioners learn how to address regulatory challenges.
Process Overview
The Product Development Process is a multi-step process from bench to commercial market.
- The first step requires that you assess the scope of your invention, discovery, idea or concept
- Define what type of industry sector it fits (i.e., therapeutics or medical technology)
- Conduct research on the market need and scope
- Align the concept with the market sector (i.e. therapeutics, medical devices, software, or technology) in which it could apply effectively
Product Categories
- Medical Devices
- In Vitro Diagnostics (IVDs)
- Pharmaceuticals and Biological Products
- Combination Products
- Biotechnology
- Accessories, Kits, and Delivery Devices
Learn More & Sign Up
To learn more about how to participate or for more information contact Michael Pratt at mpratt@bu.edu.