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Mastering your 510(k) submission process (On-Demand)

1.0 RAC Credits Member: $0 | Nonmember: $25Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
Mastering your 510(k) submission process (On-Demand)

This is an On-Demand webcast from November 2022.


Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to FDA clearance. Yet many businesses are getting it wrong: successful applications are falling, and 30% of 2021 applications weren’t even accepted for initial review.

A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.


Pricing Amounts and Deadlines

Free


Learning Objectices

  • Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
  • Learn the most common mistakes the FDA sees in applications, and how to avoid them.
  • Unpick the key ingredients of a 510(k) submission, from predicate devices and substantial equivalence to typical timelines.

Who Should Attend?

Regulatory Affairs Professionals


Speakers:

Kyle Rose

Kyle Rose, Rock Quality Systems


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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