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7th Annual Medical Device Safety Monitoring & Reporting

Ensuring Comprehensive Post Market Surveillance by Improving Tactics & Enhancing Long Term Safety

23-24 Jan 2019
Westgate Las Vegas Resort & Casino, Las Vegas, NV, United States of America

Conference Workshop

Improving Regulatory Intelligence to Ensure Long Term Safety & Efficiency

With a constantly changing regulatory system, Medical Device companies must ensure to maintain compliance. European and United States regulatory bodies drive the importance for risk management and device safety. This interactive workshop will enable improvements to regulatory intelligence and unpack new and forthcoming regulations and guidances.

Workshop Moderator: Darin Oppenheimer, Director, Regulatory Affairs

Company: Merck

Conference Workshop

Optimizing Monitoring through Enhance Post Market Surveillance Plan

Medical Device manufacturers must create and maintain an effective and efficient sequence for post market surveillance, complaint handling and reporting. Having a proactive and consistent plan enables the company to swiftly take a complaint through investigation in order to assess the risk. This interactive workshop will allow you to improve practices of post market surveillance to properly mitigate use related risk, remain globally compliant and streamline post market strategies.

Workshop Moderator:


Why You Should Attend

7th Annual Medical Device Safety Monitoring & Reporting

Medical device companies continue to face more stringent requirements fueled by concerns surrounding safety and quality of the products designed and manufactured.  In this era of heightened regulations, companies are reviewing their medical device safety protocols, assessing post-market surveillance strategy, and shoring up internal reporting protocols to achieve global compliance.  Information related to product quality, use, and effectiveness streams in from a variety of sources and companies are accountable to analyze, manage, monitor and report any potential safety related concerns.  It is a challenge to streamline the information and close communications gaps. 

Medical device companies continue to look at new strategies, tools, and technologies to achieve a more comprehensive medical device monitoring and reporting framework to ensure highest quality and safety of products. This 6th installment of the Medical Device Safety Monitoring and Reporting Conference will bring together leading professionals in regulatory affairs, compliance, post market surveillance, complaint handling, and in other related roles to address emerging compliance concerns, risk management trends, and product safety measures through a more integrated approach to monitoring and reporting. 

Key Topics

  • Improve post market surveillance strategies through efficient and effective practice
  • Mitigate safety concerns through a proactive focus on risk assessments
  • Increase voluntary complaints and improve complaint handling process
  • Unpack new and forthcoming regulations and guidances to achieve global compliance
  • Evaluate strategies for integrating regulations with products already on the market
  • Previous Attendees Include

    Acutus Medical
    B Braun Medical
    Baxter International
    Beckman Coulter
    Becton Dickinson
    Boston Scientific
    Coorstek Medical
    CR Bard Inc
    Fresenius Medical Care
    Glaukos Corporation
    Halyard Health
    LivaNova Canada Corp.
    Lumenis Inc
    Medtronic Inc.
    Microvention Inc.
    Ortho Clinical Diagnostics
    Siemens Healthcare Laboratory Diagnostics
    St. Judes Medical
    Stryker Instruments

    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
    AMS Practice Management, LLC
    Visit website >>

    Event Partners

    Practical Insights From

    Tauqeer Karim
    Vice President, Drug & Device Safety Officer
    Fresenius Medical Care

    Khaudeja Bano
    Senior Medical Director

    Darin Oppenheimer
    Director, Regulatory Affairs

    Daniel Jacob
    Medical Director
    Baxter International

    Tressa Daniels
    Senior Manager, User Experience Design and Human Factors Engineering
    Becton Dickinson

    Zach Baker
    Senior Staff Advanced Quality Engineer
    Stryker Instruments

    Arundhati Datye
    Advisor/Strategist, Medical Safety

    Aaron Larson
    Quality Manager, MDR
    Becton Dickinson

    Click Here For Full Agenda

    Voice of Our Customers
    • “A good mix of participants with valuable perspectives to share.” – Baxter International
    • “One of the best conferences since all the topics covered were relevant and timely while providing a great atmosphere for networking.” –Endologix
    • “I am new to the medical device industry. This conference was very informative and helpful for me. All the speakers were excellent and knowledgeable.” –Edwards Lifesciences
    • “Very good & broad overview of MDR process and emerging issues. Great reference material for internal training.” –Abbott Diabetes
    • ”Great interactive event and learning on topics related to medical devices, challenges and solutions. Also great for networking.” –St. Jude Medical
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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