AM Evaluation

2023 AMDM Annual IVD Regulatory Meeting Evaluation

April 19 / Session 1

China Updates / Wang *

IVDR Updates / Hoffmann *

EU Performance Study / Popp *

4-19-1 Comments *

April 19 / Session 2

EU IVDR / Trautman *

IVDR Panel *

United Kingdom Updates / Batchen *

Reimbursement / Putcha *

4-19-2 Comments *

FDA Progress Updates / Kahan *

April 20 Session 1

Real World Evidence / Hu *

Companion Diagnostics / Martinez *

Breakthrough Device Case Study / Liang *

SaMD Clinical Guidance / Payne & Levy Friedman *

4-20-1 Comments *

IVDR CE Mark Case Study / Senac *

April 20 / Session 2

COVID EUA Conversion / Meyer & Viviani *

4-20-2 Comments *

Please rate the overall event on the following using the same scale of 1 being poor to 5 being excellent:

Format & Organization *

Time Frames *

Facilities / Food *

Overall relevance / Value *

Please tell us your years of regulatory experience *

What suggestions for improvements or additions to the program would you offer? *

What speakers/topics would you like to suggest for future programs? *

Submit