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Perez, Commander Cesar
FDA (Invited)
FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
Commander Cesar Perez
Piotrkowski, Tony
Steris
Breakout #1: Addressing 510(k) Review Challenges
Tony Piotrkowski
The Device Design Change Life Cycle Experience
Tony Piotrkowski
Pontikos, Phil
FDA
Breakout #3: Are You Processing and Investigating Complaints to the Right Level?
Phil Pontikos
FDA Mock Inspection
Phil Pontikos
FDA Medical Device Inspections
Phil Pontikos
Investigator Insights
Phil Pontikos
The Device Design Change Life Cycle Experience
Phil Pontikos
Post, Justin
FDA (Invited)
Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update
Justin Post
