Device Research & Regulatory Conference
The Premier Conference for Device Professionals
Goal: This annual medical device conference, now in its 13th year, provides attendees with a main program preceded by a half-day device basics workshop. The entire program features over 13 experts presenting topics to assist those in roles specific to medical device design, development, testing, analysis, and post market management.
Attendees Include the Following Roles and Responsibilities:
- Quality, Research and Development, Regulatory
- Principle Investigators, 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
- Clinical Research Organizations
- Anyone interested in learning more about medical device research and regulatory process and hot topics
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 – a comprehensive regulatory overview
- Device Study Reimbursement Process
- Investigator-initiated Medical Device Study Process
Main Program – Day 1 Presentations Include:
- Ethics of Medical Device Innovation: Focus on the Research Subject
- Overview of the “De Novo” Process
- Explanation of HUD and HDE
- ClinicalTrials.gov: Understanding Clinical Trial Disclosure Requirements
- Post Market Clinical Follow Up: Is it Always a Clinical Study?
- EU MDR Compliance: Clinical Evaluation Reports and Clinical Evidence
- Panel Discussion: Attendee Questions and Discussion with Experts
Main Program - Day 2 Presentations Include:
- The Generationally-diverse Clinical Research Arena’
- Impacting Patient Reported Outcomes
- Risk Management Principles and Their Application in Clinical Research
- The Role of Bill of Materials in Medical Device Product Design Approval
- Multifaceted Approach to Risk-based Monitoring
- FDA Inspection Case Study
Learning Objectives: Pre-Conference Workshop
The participant will be able to:
- Discuss FDA regulations including risk categorization and device classifications.
- Understand the FDA 510(k) and PMA submission process.
- Implement adverse event reporting measures.
- Describe central CMS submissions and clinical trial billing practices.
- Explain the investigator-initiated clinical study process.
Learning Objectives: Main Conference
The participant will be able to:
- Examine ethical considerations with a renewed focus on the human subject.
- Describe the FDA De Novo process including classification and submission.
- Discuss the HUD and HDE application and approval process.
- Understand the ClinicalTrials.Gov policies requiring registration and results submissions.
- Determine EU regulatory requirements for post market clinical follow up.
- Apply knowledge of EU MDR Compliance to support clinical evaluation reports supported with clinical data.
- Participate in an active attendee-led discussion with speaker experts.
- Discuss the challenges of integrating generationally-diversity populations.
- Explain how a clear innovation process can impact patient reported outcomes.
- Comprehend risk management principles to identify and manage risks associated with clinical research.
- Examine Build of Materials (BOM) creation for product design approvals.
- Review a multifaceted approach to risk-based monitoring.
- Deliberate issues and topics germane to attendee roles and responsibilities
- 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