Events listed on BioOhio's Events Calendar are subject to change by the Event Organizer. Visit the organizer's website for current details.
Xavier Health Virtual 510(k) Workshop
July 22 - July 23
The virtual event will cover the following topics:
- History of 510(k)s as well as touching on the other approval pathways to put 510(k) into context
- Risk Management and Design Controls
- IDE and clinical data for 510(k)
- Modifications Document
- Who to engage across the TPLC to ensure al the studies, data and information are set for filing – how to mobilize an effective process in your company
The vast majority of medical devices on the market in the United States have successfully navigated the FDA 510(k) process. This strong 510(k) review process is critical to FDA’s mission of protecting and advancing public health. Expert facilitators will engage you in discussion during this hands-on, practical workshop, to provide you with firm insight on when the 510(k) process is right for your company, how to effectively support your product development with data, when to engage FDA in your 510(k) strategy, and when to notify FDA of changes to your product.
How Virtual Sessions will work:
- Highly interactive through the use of virtual breakout rooms, chat box Q&A, and live polling technology.
- Concentrated sprints to minimize time away from business matters. Rather than full days, we will have shorter sessions over multiple days.
- Recordings of each session will be available to you for two weeks after the workshop