Demystifying Medical Device Classification & Approval with MITRE
Event Information
About this event
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? How to make sure you’re obtaining proper clearance? Join our open webinar with not-for-profit organization MITRE on August 19th 10-11 AM for guidance.
Although establishing your product’s class and moving through the regulatory pathway is a required for FDA clearance, the process is not always straight forward. Operating multiple federally funded R&D centers, MITRE’s is on a mission to “work in the public interest to discover new possibilities.” FORGE is partnering with MITRE to host this free educational webinar so that more life-saving devices can get to market faster.
All startups will have the opportunity to ask MITRE experts specific classification questions about their devices during this one-hour session. We welcome any and all startups with physical products or components to join this event. The Program Manager at FORGE, Anya Losik, will be moderating the event to ensure the best experience possible. Please register and get answers about your medical device classification and regulatory pathways concerns.
Join via Zoom here: https://us06web.zoom.us/j/88393356525
Note: This event WILL be recorded.
Organizer FORGE - From Prototype to IMPACT
Organizer of Demystifying Medical Device Classification & Approval with MITRE
NOTICE FOR ALL FORGE EVENTS ATTENDEES: Please note that by participating in this event, you consent to the recording of your likeness, image, and/or voice and authorize FORGE to use photographs, video, and audio recordings containing your likeness, image, and/or voice in any medium for any purpose.
About FORGE
FORGE is a 501(c)3 nonprofit on a mission to help startups with physical products navigate the journey from prototype to commercialization and impact at scale.
THE PROBLEM
Startups making physical products are solving some of the world’s toughest problems, but face added roadblocks to scale. High early production costs and burn rate make right choices in design, supply, and manufacturing crucial to runway and success - yet many innovators have gaps in the specific connections and expertise needed to support the scaling process.
OUR SOLUTION
FORGE addresses crucial gaps and accelerates path to market for these startups by making right-fit introductions to industry expertise, combined with the training and support needed to ensure readiness for the connections to be productive.
