Design Controls & Risk Management (Mini Series)

Session I: October 6 | 12:00 - 1:00 p.m. | Microsoft Teams
Session II: November 3 | 12:00 - 1:00 p.m. | Microsoft Teams 

Building Better Products Through Structured Development
Design controls and risk management aren't just compliance tools for FDA. They are fundamental approaches to developing safer, more robust products that attract investors, funding agencies, and industry partners. In this two-part, virtual symposium series, learn how implementing both processes early, and throughout your development stages—strengthens your research, creates objective evidence, and better positions you for success and shapes products, whether you pursue FDA approval or not. Incorporating these approaches supports acceleration towards your development milestones, including clinical trials or commercialization.  Each session can be attended independently. They are most effective when attended in sequence. More details below.

SESSION I: Design Controls 101 – From Research to Market Preparedness
October 6, 2026 | 12 p.m. - 1 p.m. Central | Microsoft Teams
Whether you're developing a medical device or a research tool, implementing Design Controls creates a structured approach that separates rough prototypes from market-ready products. This session introduces formal Design Controls for software and hardware devices and tools. When you embed Design Controls, you improve your product, create efficient development workflows, document your design decisions, and generate objective evidence that funding agencies and industry partners expect. This process increases consistency across teams and collaborators, accelerating your path to development milestones and commercialization. Learn why this matters —with or without an FDA pathway. 

SESSION II: Risk Management Essentials – Building Confidence in Your Product
November 3, 2026 | 12 p.m. - 1 p.m. Central | Microsoft Teams
Smart risk management is about creating safer and more effective products with objective evidence to back your claims. It isn't just about FDA compliance—it shapes your design decisions, building more reliable products, and creating confidence with investors, users, and collaborators. This session introduces the risk management process and shows how formally defining and addressing your product's risks and mitigations strengthens your design as well as commercialization goals. Whether you're seeking FDA approval, investor funding, or industry partnerships, risk management matters.