Demystifying Medical Device Classification & Approval - Hybrid Event

110 Canal Street,Lowell MA 01853

26 July, 2022

Description

Medical device startups, are you struggling to understand the Food and Drug Administration’s (FDA) regulatory rules? Are you unsure of your product’s proper class and approval process? Are you sure of how you'll obtain proper clearance? Join our lunchtime seminar with not-for-profit organization MITRE on July 26, at noon to learn the basics. Although establishing your product’s class and moving through the regulatory pathway is required for FDA clearance, the process is not always straight forward. MITRE, operating multiple federally funded R&D centers, is partnering with FORGE and M2D2. MITRE, whose mission is to work in the public interest to discover new possibilities, joins us to deliver this educational webinar. You will have the opportunity to ask MITRE experts specific questions about the FDA process during this 90-minute session. We welcome any and all startups with physical products or components to join this event. In-person, at FORGE's Northeast MA offices, at and hosted by iHub. This is the first in an 8 part series. We plan to add a Zoom-cast too so signup for the option that works for you. Note: This event will be recorded. Please be vax'd. Masks are encouraged. This event is also repeated as part of a series.