09/12/2021
-16/12/2021
Online
As part of our commitment to driving innovation in healthcare around the world, EIT Health Gold Track is launching a new series for our start-ups focused on medical device companies that want to enter the US and have questions around regulatory aspects. These events are open to all to attend.
This two-part series brings some of the top experts from around the world to your doorstep to address the different regulatory challenges for medical devices in the US market and guide you in the process of regulatory approval.
Session 1. I want to market my product in the US and hence need regulatory approval from the FDA. What do I need to know?
Thursday 9th of December at 4:00 PM CET
Eric Bannon and Martha Kamrow-Russel will walk us through the standard regulatory approval process within the FDA for different classes of devices. They will discuss various pre-market aspects, such as planning, how to classify your device, submission, pre-submeetings, etc.
Session 2. My device got FDA clearance! Now what?
Thursday 16th of December at 4:00 PM CET
Eric Bannon and Martha Kamrow-Russell will walk us through the post market aspects of medical device regulatory processes with the FDA: we will discuss registration and listing regulations, change assessment, and post-market reporting, etc.
Meet our expert speakers from EIT Health’s Gold Track:
Eric Bannon, Vice President of Regulatory and Clinical Affairs, has over 30 years of experience providing clinical and regulatory support for medical device companies. His expertise focuses on implementing creative regulatory and clinical strategies from development through commercialization with experience in multiple therapeutic areas including Endoscopy, Orthopedics and Gastroenterology & Metabolic Diseases.
Martha Kamrow-Russell, DRSc, Director of Regulatory Affairs, has experience supporting pre-market, post-market, global and quality roles during her 20+ years in regulatory affairs. Her expertise is in ensuring medical device products meet global regulatory requirements through development, global market clearance, and post-marketing phases of product development. Martha has supported multiple businesses and facilities during inspections/audits such as MDSAP, ISO 13485, MDD and MDR.