Early-Stage Design Control for Device Development

Event description

Presenter: F. David Rothkopt, President and Founding Managing Partner of MEDICept, Inc.

Join presenter F. David Rothkopf, President, and Founding Managing Partner of MEDIcept, Inc., who will guide you to a better understanding of feasibility design control in the development and regulatory control of medical devices. Feasibility studies are a critical early step for evaluation of a medical device. This presentation is meant to be accessible to the academic and small business innovator, spanning different stages of device development. David has over 35 years of professional experience in technical and hands-on applications in a variety of regulatory, compliance management, and quality processes. In this webinar, you will gain insights into the FDA's review process, the type of controls the FDA is looking for in the feasibility stage and managing risks in feasibility studies. Time was allotted for questions and answers.

Webinar presented on April 18, 2023 to an invited audience.

This video is provided for educational purposes only.

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Chapters

0:00
Introduction
2:45
Topics of Discussion
3:50
General Comments
7:22
Why Design Control is Needed
8:17
When Does Design Control Begin
13:25
Design Input
15:50
User Needs – Why are you doing this?
17:08
Design Input
21:13
Design Control Flow – Software
23:15
Human Factors
26:00
Risk Management
27:32
Design Output
29:24
Preliminary Design Verification
31:15
Early Feasibility Studies
35:20
Questions and Answers
50:40
Upcoming Events and Reminders
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.