Two Free Medical Device Seminars

March 23, 2017

Please join us for two free medical device seminars sponsored by the Duke Office of Regulatory Affairs and Quality (ORAQ) in collaboration with ReGARDD.

April 12, 2017 | Duke North 2001

Tips for Success in Medical Device Premarket Submissions to FDA

Heather Rosecrans, FRAPS | 10:30am

This presentation will:

  • Provide valuable lessons learned from the former FDA Director of 510(k) Premarket Notification Staff
  • Cover what to expect and how to prepare for early interactions with the FDA
  • Give an overview of when to submit 510(k) and PMA applications


The Medical Device Reimbursement Life Cycle: Strategic Reimbursement Planning from Clinical Development to Commercialization

Jo Ellen Slurzberg | 12:00pm

This presentation will:

  • Provide an overview of how clinical trials, and some investigational devices may be eligible for reimbursement by Medicare and private insurers
  • Cover the inclusion of strategic reimbursement objectives to the clinical development plan
  • Introduce how clinical trials may be aligned to both regulatory and reimbursement goals

These seminars are presented as part of the 2017 ReGARDD Medical Devices Forum sponsored by the Duke Office of Regulatory Affairs and Quality (ORAQ) and Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

Register On the ORAQ Website