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3rd Annual Medical Device Safety Monitoring & Reporting

Establishing a Repeatable Safety and Reporting Model to Reduce Risks and Recalls

21-22 Jan 2015
Embassy Suites Convention Center Las Vegas, NV, United States of America

Why You Should Attend

3rd Annual Medical Device Safety Monitoring & Reporting

The marcus evans 3rd Annual Medical Device Safety Monitoring & Reporting Conference is a two-day event that will include case studies, workshops, and panel discussions from Regulatory Affairs and Quality Assurance professionals within the medical device manufacturing industry.

Building on last year’s discussion, attendees of this meeting will discuss the emerging trends in global reporting, uncover repeatable models for efficient and timely reporting processes, how to implement strategies for safer device design, and the importance of a risk-based approach to post-market clinical trials for design safety.

Attendees will be afforded the opportunity to interact with speakers and peers in a classroom style setting that will encourage engagement and yield actionable takeaways. Seating for this conference is limited to maintain an intimate educational environment that will cultivate the knowledge and experience of all participants.


Key Topics

  • Strengthening Post Market Surveillance Systems in order to Minimize Product Liability
  • Establish a Risk-Based Approach to Post Market Trials
  • Apply New eMDR Guidelines to Existing Systems to Improve Safety Monitoring and Reporting
  • Manage Product Enhancement while Avoiding Recalls
  • Integrate FDA's Mandated eMDR Requirements to Improve Current Business Practices

  • Why Choose marcus evans?

    marcus evans specialises in the research and development of strategic events for senior business executives. From our international network of 63 offices, marcus evans produces over 1000 event days a year on strategic issues in corporate finance, telecommunications, technology, health, transportation, capital markets, human resources and business improvement.

    Above all, marcus evans provides clients with business information and knowledge which enables them to sustain a valuable competitive advantage and makes a positive contribution to their success.

    Event Sponsors
    Silver Sponsor
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    Event Partners

    Practical Insights From

    Jacqueline Ryan, MD
    Medical Officer
    Center for Devices and Radiological Health Office of Compliance/Food and Drug Administration

    Sherrie Krolczyk
    Case Review Expert & National Recall Coordinator for FDA
    Food and Drug Administration/ Office of Regulatory Affairs/ Office of Operations/ Office of Enforcement and Import Operations

    Arjun D. Sharma, MD, FACC, FRCPC
    Vice President, Medical Safety
    Boston Scientific CRM

    Laurence R. Kopyta, RAC
    Vice President, Quality Assurance & Regulatory Affairs
    Omnyx, LLC

    Jacob Foster
    Senior Manager, Solutions Delivery

    Jacqueline Koonce
    Director, Patient Safety
    Covidien Surgical Solutions

    John Giantsdis, JD, CIA, CQA
    Senior Director, Corporate Quality System Compliance & Software Integration
    Fresenius Medical Care North America - Global Manufacturing Operations

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    Event Contact

    For all enquiries regarding speaking, sponsoring and attending this conference contact:

    Abby Wilson

    The NBC Tower, 9th Floor
    455 N Cityfront Plaza Drive

    (312) 894-6313
    Fax: (312) 894-6304