Dancing with the eSTARs!
Program Speaker:
Allison Komiyama, Ph.D., RAC, FRAPS
Event Agenda:
DATE: Wednesday 21 May 2025
TIME:
11:30 AM – 11:35 AM Welcome and Announcements
11:35 AM – 11:40 AM Introductions of Speaker
11:40 AM – 12:30 PM Program Presentation
12:30 PM – 12:55 PM Q and A
12:55 PM – 01:00 PM Closing Remarks and End of Session
LOCATION: This event is being offered only virtually. The zoom link will be shared with you via email 1-2 days before the event.
Registration Information:
- Register for the event here
Program Topic:
Allison is a regulatory consultant focused on FDA submissions for the medical device industry. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. Her previous company (AcKnowledge Regulatory Strategies, LLC) that she founded in 2014 was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle. Much of her recent work has been focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about Regulatory Submissions as a faculty member at SDSU Global Campus. She was an FDA reviewer for a brief stint from 2010-2011, received her Regulatory Affairs Certification (US) in 2014, and became a RAPS Fellow in 2024..
Speaker Biography:
Allison Komiyama, Ph.D., RAC, FRAPS,
VP, MedTech Innovation
Get ready for an exciting and informative webinar that dives into the latest eSTAR versions for vitro diagnostic (IVD) and non-IVD submissions, including 510(k) Premarket Notifications, PMAs, and De Novo applications. This seminar is your chance to gain a comprehensive understanding of the FDA’s expectations and learn how to expertly complete your submission files for review. We’ll cover all the basic requirements of the template and discuss the various sections needed to support the safety and effectiveness of your device; for example, biocompatibility, software, cybersecurity, electrical safety, electromagnetic compatibility, isterility, packaging, shelf-life, and performance testing. Plus, you’ll discover best practices for responding to FDA requests for Additional Information. Don’t miss this opportunity to enhance your knowledge and skills in navigating the FDA submission process. Join us for a dynamic session that promises to be both educational and engaging!
Contact
Pricing – Online – Registration (ends Tuesday, May 20, 2025)
| Registrant Type | Event Price | |
| Member | $10.00 | |
| Lifetime | $10.00 | |
| Non-Member |
$20.00
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Cancellation Policy
There will be no refunds for cancellations.
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