Associate Director, Regulatory Affairs
Network Partners
Amy Winegarden is Associate Director of Regulatory Affairs at Network Partners Group, Inc., a niche resourcing company serving the medical device, pharmaceutical and biopharmaceutical industries. With over 16 years of medical device industry experience, Amy has supported Respironics, Philips Children's Medical Ventures, Siemens Healthineers, Fisher Scientific, Smith+Nephew, and BD in technical writing, quality, and regulatory capacities.
Amy has supported products and innovation from research and development through obsolescence as an integral part of the product lifecycle team. She has authored submissions and registered product in the US (FDA), EU (MDD), and global markets and has sound experience in labeling and UDI. She currently takes a deep interest in all things Digital Health enjoying the realm of AI/AR/ML and keeping current on the latest cybersecurity threats.
Amy only started taking advantage of FDA's Q-Submission program a few years ago, but immediately recognized the value in Pre-subs, Informational Meetings, Submission Issue Requests, and other opportunities for opening up a dialogue with the FDA. Engagement with the FDA provided Amy and her colleagues a better understanding of expectations for specific devices as well as alignment on key aspects of design and submissions. She is excited to share her learnings and looking forward to the inevitable additional ideas and learnings that will come from robust discussion.
Disclosure information not submitted.
Tuesday, September 13, 2022
1:30 PM – 2:00 PM MST