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2nd Annual Risk Integration and Quality Management for Medical Devices

Operating at the Intersection of Risk and Quality to Improve All Phases of the Medical Device Lifecycle.

19-20 Jul 2017
Minneapolis, MN, United States of America

Conference Workshop

Clarifying the new ISO 13485: 2016 Standard Revision to Examine its impact on Medical Device Risk Management

Workshop Moderator: Patricia Fleenor, M.S. ASQ CQE, CQA

Company: Quality Risk Manager, Terumo BCT

Conference Workshop

Uncovering Strategies to Manage Emerging Regulatory Requirements on Risk Management and its integration with Quality Management Systems

Workshop Moderator: Weiping Zhong, Ph.D.

Company:Global Director, Risk Management, GE Healthcare

Why You Should Attend

2nd Annual Risk Integration and Quality Management for Medical Devices

Attending this marcus evans conference will enable you to take a more holistic and proactive approach to strategic risk management for medical devices. Within each device lifecycle, all potential risks are accounted for, whether they are biological, environmental, software, user error, labeling, or even a risk due to the complexity of use. In order to be effective, companies must employ continuous risk assessments to establish a baseline and categorization of the amount of risk before being able to implement controls to monitor and mitigate that risk.  Attendees will develop a strategy to mitigate risk in all phases of the device lifecycle including: planning, policies, procedures, analysis, evaluations, monitoring and controlling of risk.

The 2nd Annual Risk Integration & Quality Management for Medical Devices conference will bring together quality, regulatory affairs, and compliance professionals to benchmark current risk management strategies against other peer organizations, interpret new FDA and European guidance’s, as well as analyze the ISO 13485 and 14971 standards.


Key Topics

  • Navigate the changing regulatory landscape to understand the new FDA regulations and ISO standard revisions.
  • Prepare for FDA and EU audits to ensure readiness and streamline internal processes.
  • Integrate risk management in cybersecurity activities to ensure safeguards against potential device threats or breaches.
  • Utilize risk assessments as a tool to improve safety and streamline medical device development.
  • Implement actionable strategies for post-market surveillance complaints and incidents to determine course of action.
  • 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 Partners

    Practical Insights From

    Lorie Erikson
    Consumer Safety Officer, Cardiovascular Devices Branch, Office of Compliance and Division of Manufacturing and Quality, Center for Devices and Radiological Health
    U.S. Food and Drug Administration

    David Joppru
    Global Supplier Quality
    Boston Scientific

    Robert Steele
    Vice President, Quality Assurance and Regulatory Affairs

    Laura LeBoeuf
    Vice President, Quality, Regulatory, Clinical
    Apollo Endosurgery, Inc.

    Thomas Bento
    Senior Vice President, Quality & Regulatory Assurance
    Nihon Kohden America

    Pearley Bhambri
    Senior Director, Global Quality Systems & Post- Market Surveillance
    Hill-Rom, Inc.

    Kathleen Whanger
    Senior Manager, Quality Assurance
    Teleflex Medical

    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:

    Angelica Anselmo

    455 North CityFront Plaza Drive
    9th Floor NBC Tower
    Chicago, IL, 60611

    Fax: 312-894-6304