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Workshop

The Device Design Change Life Cycle Experience

Tuesday, April 22, 2025
8:30 AM – 4:30 PM East Coast USA Time
Location: Franklin B – 2nd Floor
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.

Pre-Conference Workshop Agenda

8:30 - Introduction and Agenda
8:35 - Introduction of the device and change to consider
9:35 - Evaluation of the change/ Impact Assessment – Part 1
10:15 - Break
10:30 - Evaluation of the change/ Impact Assessment – Part 2
11:15 - Risk management
12:15 - Lunch
1:15 - Verification/validation
2:15 - 510(k) submission decisions – Part 1
2:45 - Break
3:00 - 510(k) submission decisions – Part 2
3:30 - Potential recalls/field corrections
4:15 - Closing Remarks