Medical Devices and the FDA: Series Spanning Key Topics

Medical device startups, are you challenged to understand the Food and Drug Administration’s (FDA) regulatory rules? Are you unsure of your product’s proper class and approval process? Will you be able to obtain proper clearance? Do you know how to obtain an IRB and work with an external medical facility? How about the best strategy for the fastest approval? And, what about clinical data and trials?

FORGE, M2D2, MITRE and iHub join forces with subject matter experts to dive into the steps and challenges of this critical, yet complex process!

You will have the opportunity to ask experts specific questions about the FDA process during each 90-minute session. We welcome any and all startups with physical products, consumables, wearable or components expected to need FDA clearance to go to market.

This is an 8 part series so join for the topics that you need to understand. In-person, at FORGE’s Northeast MA offices, at and hosted by iHub. The recurring “FDA 101” will also be offered on Zoom.

September 22, Preparing for pre-submission