ASSOCIATION OF MEDICAL DIAGNOSTICS MANUFACTURERS
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2019 Submissions Workshop Evaluation
Please use the scale below to rate the following speakers in terms of content and delivery:
1=Unsatisfactory 2=Fair 3=Satisfactory 4=Good 5=Excellent
April 8 / Morning Sessions
OIR Update / St. Pierre
*
5
4
3
2
1
Division of Industry.../ Freeman
*
5
4
3
2
1
Registration and Listing / King
*
5
4
3
2
1
MDR / Arnold
*
5
4
3
2
1
510(k) Program / Shulman
*
5
4
3
2
1
Precision Medicine / Donigan
*
5
4
3
2
1
Comments
*
April 8 / Afternoon Sessions
CLSI: Overview / Kondratovich
*
5
4
3
2
1
Third Party / Hill
*
5
4
3
2
1
DeNovo 510(k) / Balsam
*
5
4
3
2
1
Pre- and Post-Market Cybersecurity / Carmody
*
5
4
3
2
1
Submissions for Molecular Devices / Bijwaard
*
5
4
3
2
1
Companion Diagnostics / Gallagher
*
5
4
3
2
1
Comment
*
April 9 / Morning Sessions
Pre-Submissions and Q-Subs / Haznadar
*
5
4
3
2
1
Bioresearch Monitoring/ Allen
*
5
4
3
2
1
Quality Regs. & Compliance / Mallonee
*
5
4
3
2
1
IDE / Donigan
*
5
4
3
2
1
Health Hazard Evaluation/ Pilcher
*
5
4
3
2
1
April 9 / Afternoon Sessions
CLIA Processes... / Tobin
*
5
4
3
2
1
CLIA Waiver / Kondratovich
*
5
4
3
2
1
Guidance Highlights / Sauer
*
5
4
3
2
1
Ask the FDA / Panel
*
5
4
3
2
1
Please rate the overall event on the following using the same scale of 1 being poor to 5 being excellent:
Format & Organization
*
5
4
3
2
1
Time Frames
*
5
4
3
2
1
Facilities / Food
*
5
4
3
2
1
Overall relevance / value
*
5
4
3
2
1
Please tell us your years of regulatory experience
*
Less than 1 year
2-5 years
6-10 years
11-15 years
16-20 years
20+ years
What suggestions for improvements or additions to the program would you offer?
*
What speakers/topics would you like to suggest for future programs?
*
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About
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