Training Program Title

Device Research & Regulatory Conference: The Premier Conference for Device Professionals

CTSA Hub Administered


Contact Information

Contact us by email at or call us at 215-822-8644.

Training Program Description

Goal: This annual medical device conference, now in its 13th year, provides attendees with 2 days of speakers from FDA, site, industry and clinical research/regulatory support organizations. We also host a Pre-Conference Half-Day Workshop as an add-on to the Main Program.

Attendees Include the Following Roles and Responsibilities:

  • Quality, Research and Development, Regulatory
  • Clinical Research Associates, Clinical Research Coordinators
  • Government, University, Industry Representatives
  • Engineering, Human Factors
  • Medical Device Designers/Developers
  • Medical Device Startups
  • Medical Device Vendors, Service Providers

The Pre-Conference Half-day Workshop is designed to provide a comprehensive medical device regulatory overview and is a fundamental precursor to the Main Program and includes:

  • Demystifying Medical Devices
  • How Can Knowledge of Good Laboratory Practice (GLP) Regulations Make Your IRB Minimize Patient Risks?
  • What is Q-sub and the FDA’s Pre-Submission Program

Main Program – Day 1 Presentations Include:

  • Introduction to the 510(k) Program and Case Study
  • Introduction to the PMA Program
  • A Key Resource for Industry – Working with the CDRH Office of the Ombudsman
  • Navigating the FDA/CDRH Website
  • US Clinical Trial Reimbursement
  • Balancing the Clinical Trial Budget
  • Panel Discussion

Main Program - Day 2 Presentations Include:

  • The Ten Best Innovation Practices Among Healthcare Innovation Centers
  • Risk Management in Medical Device
  • European Union Changes in Medical Device Regulations
  • Medical Post Market Clinical Follow-up (PMCF): Adjusting to the “new normal” in the MDR Era
  • Managing Medical Device Product and Project Lifecycles in an Evolving Regulatory Landscape
  • Medical Device Jeopardy

Competency Keywords

Device, Product development, Research study management, Regulation, Best practice

Digital Commons Disciplines

Medical Education



Cost to Access


Competency Domains

Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations; Study and Site Management

Learning Objectives

Learning Objectives: Pre-Conference Workshop

The participant will be able to:

  • Discuss FDA regulations including risk categorization and device classifications.
  • Describe Good Laboratory Practice and how it can be used to assist IRB review.
  • Discuss FDA CDRH Pre-Submission process.
  • Discuss during Question & Answer with speakers to gain additional understanding of the FDA Regulatory Process and particular experiences.

Learning Objectives: Conference

The participant will be able to:

  • Discuss 510(k) process relative to submission requirements.
  • Describe the Premarket Approval Program assessing safety and effectiveness of Class III devices.
  • Discuss value and process to utilize Ombudsman resources, particularly for dispute resolution.
  • Describe resources available through the FDA CDRH website.
  • Discuss US clinical trial reimbursement.
  • Apply budget approaches to maximize reimbursement and expectations.
  • Discuss a DUKE-led study regarding how healthcare innovation centers launched initiatives and how they compare to industry.
  • Discuss risk management and the total product life cycle and human factors related process.
  • Explain European Union Changes in Medical Device Regulations that will impact compliance.
  • Comprehend Post Market Clinical Follow-Up
  • Discuss tools and process to promote a partnered approach to protocol development.
  • Actively discuss issues and topics germane to attendee roles and responsibilities

Delivery Method


Target Learners

Clinical Research Professionals (other than PI)

Learning Level






Time Needed

2 Day Conference (17.75 hours of CE credit available)

Associated Assessment


Assessment Methods

Overall satisfaction