…survey of individuals that use or develop surrogate samples and analysis of publicly available IVD submission data via FDA’s Premarket Notification and Premarket Approval databases (e.g., 510(k) summaries, SSEs). https://www.youtube.com/watch?v=Nr1GNW6f8o8&feature=youtu.be…
…improvement. Speakers Pat Shafer and Pat Baird present this webinar on the Value of Quality whitepaper, a Cost of Poor Quality dashboard and a whitepaper on Management Review Guidance. https://www.youtube.com/watch?v=dp6BhSZV6LE&feature=youtu.be…
…with some additional considerations for quality and efficient medical device clinical trials. This joint webinar provided an overview of both groups’ effort to promote clinical trial quality by design. https://www.youtube.com/watch?v=Dg9qKrbcSfE&feature=youtu.be…
…and product quality outcomes analytics for hospital value analysis teams. Our goal is to drive the medical technology community to focus beyond compliance to the drivers of product quality. https://www.youtube.com/watch?v=e5MHRCDc-qI&feature=youtu.be…
…Patient Preference Framework and the CDRH draft guidance on patient preference as well as case studies of patient preference studies and the impact of those studies on product development. https://www.youtube.com/watch?v=5nh9xsPbib4&feature=youtu.be…
…two or more products, technologies or systems to exchange information and to use the information that has been exchanged.” Slides and links: Bakul Patel and Julian M. Goldman, MD https://www.youtube.com/watch?v=JYMCOp-vDQY&feature=youtu.be…
…experiences from sponsors who have submitted Early Feasibility Studies to CDRH. Speakers include: Owen Faris and Carla Wiese, CDRH; Angela Mallery, NAMSA; Vicki Pearson, Medtronic; and Karim Benali, Abiomed https://www.youtube.com/watch?v=DLLw-puzJNM&feature=youtu.be…
…multi-center clinical trials. Featured speakers included: Cynthia Hahn, Chief Operating Officer, The Feinstein Institute for Medical Research and Soo Bang, Sr. Director, Global Alliances & Business Development, Celgene Corporation https://www.youtube.com/watch?v=0IWFutpZwaM&feature=youtu.be…
…into the development and submission of new medical technologies. Following Ross’ presentation, Annie Saha from FDA’s CDRH gives an overview of the draft guidance released on May 13, 2015. https://www.youtube.com/watch?v=dWuoKeoX22c…
