Accelerate your product development.
Loading Events

« All Events

  • This event has passed.

AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR

April 14, 2022 @ 12:30 pm - 1:30 pm

Free

Ted Heise, PhD, RAC, Vice President of Regulatory and Clinical Services, will be a panelist on this upcoming webinar.

What will attendees learn?

  • What’s required by FDA to get into an IDE trial: Hint: robust design history files, and answers to questions that validate or confirm clinical hypotheses.
  • What clinical trials need to answer in order for the greatest potential for regulatory approval. Hint: key players include regulatory associates, internal review boards, contract research associates and design history file team members.
  • Clarity on pathway to regulatory approval in clinical use and broad patient populations.

Who should attend?

  • Early stage medical device and technology companies
  • Academic investigators
  • Physician entrepreneurs
  • Clinicians interested in participating in clinical studies
  • Investors in new medical technologies who want to ensure capital efficient design, development and regulatory approval pathways for their invested companies

Details

Date:
April 14, 2022
Time:
12:30 pm - 1:30 pm
Cost:
Free
Website:
https://gcmiatl.com/2022/03/07/webinar-an-intro-to-the-fda-investigational-device-exemption/

Organizer

GCMI

Venue

Live Virtual

OUR COMMITMENT

We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 4.98/5 points (9).