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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Navigating the FDA’s Medical Device Presubmission Process

Published Date: January 14, 2025

This webinar provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. The presenters will examine the strategic advantages of utilizing the pre-submission program (Q-Sub), outlining key components and benefits. This webinar is ideal for medical device manufacturers, regulatory professionals, researchers, and anyone involved in developing and commercializing medical devices in the United States.

Learn more about the presenters below.

Thor Rollins

Thor Rollins

RM (NRCM)
Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Jordan Elder

Jordan Elder

Regulatory Affairs Expert

Jordan has 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for pharmaceutical and medical device companies. As Director of Regulatory Affairs for Regulatory Compliance Associates (RCA) he is responsible for providing clients with general direction, tactical objectives, and functional plans for their regulatory needs. Jordan is a meticulous regulatory professional with...

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Anita Michael

Executive Principal Consultant, Pharma Compliance, Regulatory Compliance Associates

Anita has over 24 years of global regulatory and quality experience, including 16 years operating globally as a pharmaceutical expert, FDA investigator, and FDA pre-approval manager. She specializes in preparation, remediation, and designing of training for individuals at all levels of an organization.

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