Events Calendar

As a member benefit, MassMEDIC holds an Annual Conference in May, an Annual MedTech Investors Conference in October and a series of informational programs throughout the year on a wide range of topics of interest to MassMEDIC members, including regulatory affairs, product development trends and reimbursement issues.

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  1. Dec
    12
    Tue

    1. FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS
      8:00 am – 3:30 pm

      Collaboratively hosted by the ASQ Biomedical Division/New England Discussion GroupMassMEDIC and RAPS, this daylong program is designed to give RA, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials, industry representatives and regulatory experts.

       

      AGENDA

      7:00 am

      Registration / Coffee / Networking

      8:30 am

      FDA – Update on Current Policies and Priorities
      Vernessa T. Pollard, Partner, McDermott Will & Emery

      CDRH Report
      William H. Maisel, MD, MPH
      Director, Office of Device Evaluation (Acting); Deputy Director for Science and Chief Scientist, Center for Devices and Radiological Health, U.S. Food and Drug Administration

      10:00 am

      Networking Break

      10:30 am

      FDA New England District Office Update
      Joseph Matrisciano, District Office Director, U.S. Food and Drug Administration

      Digital Health Initiatives at FDA
      Heather Agler, Sr. Science Health Advisor, Center for Devices and Radiological Health, U.S. Food and Drug Administration

      12:00 pm

      Luncheon 

      1:00 pm

      EU MDR: Review of Significant Changes and Timeline for Manufacturers
      Glen Emelock, Senior Partner, The CRO Group, Inc.; Lead Auditor/Product Reviewer, National Standards Authority of Ireland

      Dissecting Newly Released ODE Guidance Documents: What’s New, What’s Not, and How Will They Impact Your Submission Strategy
      Sheila Hemeon-Heyer, MS, JD, FRAPS, Founder and President, Heyer Regulatory Solutions LLC

      2:30 pm

      Program Concludes

       

      SPONSORS

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      8:00 am
      FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS

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