2022 NCRAF Device Workshop

If you have questions about this course please contact rac_workshops@ncraf.org

Course Details

Syllabus
Agenda
Introduction
Introduction by Maria Oyaski
Regulatory Authority Meetings
Regulatory Authority Meetings by Kevin Barber
Good Clinical Practice
Good Clinical Practice by David Jensen
Device Classification
Device Classification by Maria Oyaski
Good Laboratory Practice
Good Laboratory Practice by Brenda Faiola
Investigational Device Applications
Investigational Device Applications by David Jensen
Medical Device Software
Medical Device Software by Sheila Hemeon-Heyer (2020)
CMC/Quality System Design & Development
CMC/Quality System Design & Development by Scott Burian
Clinical Protocols and Clinical Development Plans
Clinical Protocols and Clinical Development Plans by Nicholas Kenny, Jack Modell, Ben Vaughn
In-vitro Diagnostic Reguations
In-vitro Diagnostic Reguations by Maria Oyaski
510(k)_PMA_Canada_EU_International
510(k)_PMA_Canada_EU_International by Ken Butz
MedicalDevice_DesignProcess_DesignControls
MedicalDevice_DesignProcess_DesignControls by Cheng Li
Prescription Product Labeling
Prescription Product Labeling by Theresa Scocco and Joseph Watson
Medical Device Special Programs
Medical Device Special Programs by Kevin Barber
Pharmacovigilance and Risk Management
Pharmacovigilance and Risk Management by Lisa Hornick
Combination Product Overview
Combination Product Overview by Judy Hauser
Compliance_Inspections_Enforcement
Compliance_Inspections_Enforcement by Drew Barlow
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