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Risk Integration and Quality Management for Medical Device

Effectively Stratifying Risk throughout the Product Lifecycle

22-23 Jul 2015
The Westin- San Diego, CA, United States of America

Why You Should Attend

Risk Integration and Quality Management for Medical Device

This marcus evans conference presents a unique and holistic approach to effectively managing risk. Case study presentations will tackle how to adopt an integrated and proactive approach to risk management and product safety. Attendees will develop a strategy to incorporate risk management throughout all phases of the product lifecycle.

We will address the proactive trends facing risk management and quality assurance as fundamental parts of each stage of development. Additionally, we will extend the understanding of exigent International Organization for Standardization (ISO) standards to better equip medical device professionals for integrating risk management throughout quality, regulatory, and compliance areas and developing a robust risk plan.

By bringing together leading professionals in Quality, Regulatory Affairs, and Compliance; participants will have the opportunity to benchmark current risk management strategies against other peer organizations as well as interpret new FDA guidance.

Key Topics

  • Develop a robust and integrated risk management plan to improve quality management and product success
  • Revitalize risk reporting to enhance management and mitigation effects
  • Anticipate and React to changes and updates in risk management requirements to ensure compliance
  • Establish the vitality of risk management to improve functionality
  • Synthesize risk management efforts with those of regulatory and notified bodies to streamline compliance efforts
  • Previous Attendees Include

    Penumbra Inc, Wipro Technologies, Draeger, Acclarent, Fresenius Medical Care, Elekta Limited, Novocure, Covidien Gi Solutions, Draeger, Coloplast Corp., Suneva Medical Inc., Bayer Healthcare, Halyard Health, Medtronic Inc., St. Jude Medical, GE Healthcare, Integra Lifesciences, Intuitive Surgical Inc, Zimmer Inc., Medtronic Neuromodulation, Cardinal Health, Merit Medical Systems, Edwards Lifesciences, McKesson Corporation

    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
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    Event Partners

    Practical Insights From

    Sharon Kapsch
    Chief, MDR Policy Branch, Office of Surveillance and Biometrics
    US Food and Drug Administration

    Marc Wilson
    Public Health Analyst, Chief, MDR Policy Branch, Office of Surveillance and Biometrics, Center for Devices and Radiological Health
    US Food and Drug Administration

    Judith O'Grady
    Corporate Vice President Global Regulatory Affairs
    Integra Life Sciences

    Manfred Walder
    Vice President, Quality Systems

    Paul Landesman
    Vice President of Quality, Regulatory, and Customer Service
    Dictum Health

    Larry Koptya, RAC
    Vice President of Quality Assurance and Regulatory Affairs
    Omnyx, LLC

    Orlando Guillory
    Director, Quality Engineering
    Edwards Life Sciences

    Click Here For Full Agenda

    Voice of Our Customers
    • "Thie conference was very well done, very well organized. I have attended numerous, and I would put this in my top five."
    • "This was a perfectly balanced agenda. The topics were all relevant to aspects concerning medical devices. The speakers were excellent. The smaller group dynamic made the discussions more meaningful."
    • "Overall, great use of two days. I learned many nuanced points on topics I felt I already had a good handle on."
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    Event Contact

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

    Monique Filardi

    The NBC Tower
    455 North Cityfront Plaza Drive (9th Floor)
    Chicago, IL 60611

    312 625 0164
    Fax: 312 540 3020