Thank you for your interest in Freyr’s Webinar Series (FWS). The webinar on ‘Foundation Masterclass: 510(k) Clearance Pathway’ will be held on September 07, 2022, for AMR, EUA & ROW regions.

What Is It All About?

Annually, more than 500 devices are cleared through the 510(k) program. Preparing for the 510(k) submission can be demanding for medical device and IVD manufacturers. The applicants must have a thorough understanding of the 510(k) checklist and the US FDA requirements for right-first-time success. To enhance the perspective on the factors driving the 510(k) pathway like determining predicate device, key considerations, and the compliance best practices, Freyr brings you a comprehensive webinar on:

Foundation Masterclass: 510(k) Clearance Pathway

September 07, 2022

Duration – 60 Minutes

Join the Webinar at your Convenient Time

For AMR & EUA Regions

10:00 AM EDT | 04:00 PM CEST | 03:00 PM BST

For RoW Region

11:30 AM IST | 04:00 PM AEST

Host

Kristen Laudicina

Client Partner, Medical Devices

Kristen Laudicina is the Client Partner for Freyr’s Medical Devices Center of Excellence (CoE). She currently oversees the North and South American regions and supports Freyr’s Medical Device CoE team. Kristen has 13+ years of experience within Life Sciences, from Preclinical through Commercial Manufacturing, and understands the client’s needs from both a Sponsor and Service Provider perspective.

Presenter

Shilpa Gampa

Medical Device Regulatory Affarirs- US, Canada and EU

Shilpa Gampa has been working as a Regulatory Affairs professional for over 7+ years, and has rich experience in diversified Medical Device categories and has supported organizations ranging from small start-ups to multi-national corporations. As an experienced Regulatory professional, Shilpa’s core work involves managing strategic services for Freyr’s global Medical device clients for their US, Canada, and EU Medical Device Regulatory requirements. Shilpa has a Master’s degree in Regulatory Affairs.

In this webinar, our in-house Regulatory experts, Shilpa Gampa and our host Kristen Laudicina will discuss the following:

  • How to identify and narrow down predicate devices for 510(k) clearance
  • Effective strategies for establishing a substantial equivalence with the predicate device
  • Key considerations for digital health product submissions
  • When to opt for Pre-submission and Q-submission meetings with US FDA
  • Major deficiencies during the substantiative review and how to avoid them
  • Do and don’ts for the eSTAR program 
  • Case studies
  • Frequently Asked Questions (FAQs) on 510(k) registrations

 

Given the keynotes and with due respect to your busy schedule, we look forward to seeing you at the webinar. Register now! Stay informed. Stay compliant.