Events

Design Controls for the Medical Device Start Up

A must attend for small medical device companies, new inventors, PIs and engineers. Gain an imperative understanding of when to stop “R” and start “D” and what it entails.

PROGRAM

7:15-7:50 AM
Networking Continental Breakfast
8:00-10:45 AM
Essentials of Design Control
GLP – Applicability & Key Requirements
Premarket Regulatory Compliance: Current FDA Perspective
The Importance of Quality & Compliance in an Exit Strategy

SPEAKERS AND PANELISTS

Teresa Thompson
FDA District Director, Cincinnati
Georgia Layloff
Independent consultant, ex FDA Investigator
Michael H. Southworth
RAC / Principal, Southworth & Associates, LLC
Christian Haller
Director of Technology, MPR