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 Register Now For RoW Region 11:30 AM IST | 04:00 PM AEST Register Now 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.