Workshop

The Device Design Change Life Cycle Experience

Tuesday, April 22, 2025

8:30 AM – 4:30 PM East Coast USA Time

Experience the life-cycle of a medical device design change from a panel of experts who will guide you through interactive activities to resolve the complex pathway from initiation to implementation. Topics will include evaluation of the change, risk management, verification/validation, 510(k) submission decision s, potential recalls/field corrections, as well as other surprises that you and your firm may encounter while navigating the path of a medical device design change.

Please note: The workshop is an additional cost to the MedCon Conference. Please see the registration page for more details.

Moderator(s)

Bill Brodbeck

Vice President, Regulatory Affairs
STERIS Corporation, Ohio, United States

Speaker(s)

David Elder

Principal, Quality & Compliance
Eliquent Life Sciences
Evan Markley

Associate Director Digital Health Solution Delivery
Eli Lilly and Company
Chitra Nadig

Director of Quality and Regulatory
KeborMed
Tony Piotrkowski

Director of Regulatory Affairs
Steris
Phil Pontikos

Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)
FDA