NAMSA and the Regulatory Affairs Professional Society (RAPS) will hold this webinar to bring awareness to the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) proposed changes and what these may mean for the medical device industry and MedTech manufacturers as a whole.
Medical Device & Equipment
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In healthcare, we often hear the phrase “patient focus” which is designed to make decisions with the patient’s safety in mind. But all too often we forget that within the workplace, we also need to consider the safety and well-being of our sterile processing professionals who are facing the risks and doing the real work. This presentation will focus on the dangers and risks we face on a daily basis in our departments as well as provide solutions for those dangers and risks. |
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On this edition of Founder’s Story, Rev 1 Ventures will host a breakfast with DASI Simulations’s team who performs advanced individualized computational predictive modeling powered by artificial intelligence and computer vision to better plan for improved patient outcomes and reduced costs associated with Structural Heart Disease.
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A dramatic shift in regulatory opinions has occurred within the last several years regarding the concepts of Extractables and Leachables (E&L) testing of medical devices, commonly known as Chemical Characterization. Much of that change was driven by the 2020 revision to ISO 10993-18. Join NAMSA for this webinar to learn more about the foundations behind Chemical Characterization and to examine best practices deriving from it. |
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