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Location: Room 207C
Title: NAMSA: The Biological Evaluation of Medical Devices—Choose your Adventure
Event Type: Workshops
NAMSA will present a half-day training focused on the biological evaluation of medical devices: “The Biological Evaluation of Medical Devices—Choose your Adventure.” Led by a qualified instructor, attendees will choose their own adventure for medical devices through the evaluation process.
Presented will be information on two different devices and device pathways to regulatory acceptance focused on biological evaluation. During this time, attendees will provide input and choose an intended path, by device, based on which will yield regulatory acceptance. Key focal points of this adventure will be challenges faced by varying regulatory authorities, ISO 10993–1, 10993–18 and 10993–17, just to name a few.
This session is ideal for professionals with a basic understanding of the biological evaluation of medical devices and wish to further learn how an experienced leader would evaluate different devices for biological safety. For the less experienced attendees, we recommend a thorough review of any available webinars as well as reading of ISO 10993–1, 10993–18 and 10993–17 to better understand the process of the biological evaluation of medical devices.
Attendees of this session will:
Evaluate various details of what is known about materials and device histories to help outline biological evaluation plans
Demonstrate different paths to regulatory submission
Overcome challenges that may be presented by different regulatory agencies
