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* * * 2020 CANCELLED * * *
(2021 Info Coming Soon)

Proactively Identify Industry Complexities, Regulatory Guidelines and Innovative Best Practices for Risk Management

In its 16th year, this leading event provides strategies for organizations to prevent future recalls and complaints. Interactive and engaging sessions have been designed to address FDA regulations, upcoming trends, risk-based decision making and ways to navigate automation processes.

What to Expect

Complaint Analysis and Reporting Initiatives
Complaint Analysis and Reporting Initiatives
  • Utilizing Statistical Analytics to Set Complaint Thresholds
  • Trend Analytics – Leveraging AI and Automation
  • Post-Market Safety Reporting for Combination Products
  • Impacts of Connectivity-Devices on the Complaint Handling Process
  • Complaint Handling of Traditional vs. Connected Devices
  • Review Single Patient INDs and the Right-to-Try Law
End-To-End Recall Management
End-To-End Recall Management
  • Process Review and Strategic Approaches to Recall Execution
  • Defining Recalls – Identifying Enhancements and Acceptable Defect Rates
  • Bolster Quality Management System for Recall Prevention
  • Hospital Insight into Best Recalls and Complaints Practices and Regulatory Expectations
  • Post-Market Risk Monitoring for Digital Medical Devices
  • Conducting Health Hazard Evaluations (HHE) Through Critical Thinking Processes


Gain Insight & Updates from FDA and Industry Leaders
Gain Insight & Updates from FDA and Industry Leaders

(2018/2019 Speaker Highlights)

  • Cecilia Wolyniak, Lead Consumer Safety Officer, ORA, FDA
  • George Cusatis, Associate Director Device and Digital Health, Merck
  • Erik P. Mettler, Assistant Commissioner, MPA, MPH, ORA, FDA
  • Khaudeja Bano, Senior Medical Director, Medical Device Safety Head, Abbott

Connect and Network with Key Decision-Makers at Product Recalls & Complaints

Whether you’re looking to generate quality leads, showcase thought leaders, or reinforce your brand, collaborate with us to identify custom sponsorship opportunities to help you reach your business objectives.

For more information about opportunities to reach a qualified audience, contact