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About the HHE, Benefit-Risk and Recalls Conference

May 17 - 18, 2017

The fifth annual MedTech Intelligence medical device recalls conference will feature senior level CDRH and industry speakers for in-depth discussions of a range of new topics, including new FDA initiatives, the practical application of benefit-risk to recalls, the use of decision analysis, the Risk Assessment Form, clinical versus engineering perspectives on risk, procedures and expectations for recall termination, and hospital recommendations for more effective recall communications and processes.  The conference will also include examples and discussion of best practices for internal recall processes, communications, recall do-overs, effectiveness checks, and other topics of practical importance.

Presented as a hybrid event, plan to attend this conference in person, in Washington DC or from your desktop.

Topics will include:

  • CDRH recall updates
  • Status of recent guidances and current initiatives
  • FDA’s Benefit-Risk Guidance
  • Transparency and alignment of FDA and industry HHE procedures
  • When to launch an HHE
  • Data sources for HHEs
  • Evaluating health hazards with incomplete or uncertain information
  • Case studies analyzing HHE best practices
  • Feeding HHE and recall results back into other regulatory and quality functions
  • Communicating with FDA during HHEs and recalls
  • Investigating, documenting, and reporting non-recall field actions
  • Risk assessment and recall decisions
  • Internal deliberations and procedures leading up to recalls
  • Recall communications to health care providers, distributors, patients, investors, the press, and other stakeholders
  • How hospitals, physicians, and other end users experience the recall process
  • Managing expanding recalls

The fifth annual MedTech Intelligence medical device recalls conference will feature senior level CDRH and industry speakers for in-depth discussions of a range of new topics, including new FDA initiatives, the practical application of benefit-risk to recalls, the use of decision analysis, the Risk Assessment Form, clinical versus engineering perspectives on risk, procedures and expectations for recall termination, and hospital recommendations for more effective recall communications and processes. The conference will also include examples and discussion of best practices for internal recall processes, communications, recall do-overs, effectiveness checks, and other topics of practical importance.

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. Medical Device Summit will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

Medical Device Summit's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

  • When

  • Wednesday, May 17, 2017 - Saturday, May 19, 2018
    8:30 AM - 5:00 PM

  • Where

  • Hogan Lovells
    555 Thirteenth Street, NW
    Washington, District of Columbia 20004
    USA

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