Program Description

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

Goal: This annual medical device conference provides attendees with a main program preceded by a half-day device basics workshop. The entire program features experts presenting timely medical device-related research and regulatory topics.
Attendees include the following roles and responsibilities:

  • Clinical Research Professionals (e.g., Principal Investigators, Clinical Research Associates, Clinical Research Coordinators, Project Managers, Operations Managers)
  • Government, University, Industry, and Support Organization Representatives
  • Quality, Regulatory, Research and Development, Engineering, Human Factors
  • Medical Device Designers/Developers
  • Medical Device Startup Companies
  • Medical Device Vendors, Service Providers
  • Clinical Research Organizations
  • Anyone interested in learning more about medical device research and regulatory process
Preconference Workshop

The preconference half-day workshop is designed to provide a basic regulatory overview specific to medical device and is a fundamental precursor to the Main Program. Topics include:

  • Overview of medical device through terminology
  • Device specific regulations and classification
  • Good Clinical Practice
  • Roles, Responsibilities, and Study Monitoring
  • Premarket Submissions

Main Program

Day 1 Presentations:

  • ISO 14155:2020 overview and comparison to FDA IDE regulations
  • Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program
  • Lessons Learned: IDE Case Study
  • Impact of the European Union General Data Protection Regulation and Other Privacy Laws on Clinical Research
  • Privacy & Confidentiality in the Age of Mobile Apps and Connected Devices
  • Speaker Panel

Day 2 Presentations:

  • The Ethics and Regulation of Medical Device Innovation
  • Investigator-Initiated Device Studies – Key Concepts and Unique Challenges
  • Use of Clinical Adjudication for Determination of the True Infection Status in the Absence of Reference Standard
  • Effective Management of Clinical Trial Financials
  • Collaboration for Effective Monitoring Visits
  • Effective Management of Clinical Trial Financials
  • Introduction to Statistics in Medical Device Research
  • Speaker Panel

Learning Objectives: Pre-Conference Workshop

The participant will be able to:

  • Discuss FDA medical device terminology as an introduction to the workshop.
  • Describe regulations, including risk categorization and device classifications.
  • Understand the types of premarket submissions submitted to CDRH as well as best practices and strategies for submissions.
  • Examine Good Clinical Practice for medical device as well as the roles and responsibilities key partners in clinical research.
  • Review and share medical device study monitoring processes.
  • Ask questions in an interactive question and answer session

Learning Objectives: Main Conference

The participant will:

  • Differentiate the international ISO 14155 standard requirements from the US FDA IDE 21CFR812 Regulations.
  • Review the practical aspects of citing standards in device submissions and learn tips on why and how to participate in the Accreditation Scheme for Conformity Assessment (ASCA), Center for Device and Radiological Health’s new initiative to streamline conformity assessment in device review.
  • Describe IDE risk determination and the regulatory framework.
  • Understand how the GDPR and certain U.S. state privacy laws affect clinical research involving medical devices.
  • Describe the impact of mobile applications and connected devices on the privacy and confidentiality of research subjects and practice steps to assure such protections.
  • Identify and address ethical and regulatory considerations in medical device research.
  • Articulate the full set of responsibilities taken on by a Principal Investigator who is both the sponsor and investigator of a device study.
  • Understand the key regulatory concepts that inform the fundamentals of device investigator-initiated research.
  • Identify site specific trial costs to include in sponsor budgets and gain confidence in negotiation skills.
  • Appreciate the preparation required to find success during an FDA inspection.
  • Increase collaboration to ensure effective and efficient monitoring onsite and remote monitoring visits.
  • Learn the concept of clinical adjudication, how it works and how it has been incorporated in clinical trials in the past along with current successful use for a 510K submission.
  • Understand the general statistics presented in medical device regulatory submissions and academic publications.
  • Participate in speaker panel discussions held at the end of each day.