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Notified Bodies continue to see most non-conformances in clinical evaluation, leading to the conclusion that there is not sufficient clinical evidence. A review of common questions from the notified bodies suggests that manufacturers struggle to understand how to define safety and performance outcomes and analyze the data.
This presentation will discuss how to identify meaningful safety and performance outcomes. Participants will learn how the clear definition of the safety and performance outcomes, together with the results of the state-of-the-art evaluation, will serve as the foundation required to conduct an analysis of the data and support the determination if there is sufficient clinical evidence.
A live Q&A portion with the speaker will follow the presentation.
RAPS Chicago Chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.
Learning Level: Intermediate
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
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How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.
Featured Speaker:Mindy McCann, Vice President, Compliance, Principal Consultant, Qserve Group US, Inc.
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RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Registration fees for this event are nonrefundable.
Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.