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. Nov
    29
    Wed

    1. MassMEDIC Webinar: ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices
      12:00 pm – 1:00 pm

      Register for free here.

      Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan.

      In today’s world, however, the simplicity of the above process is increasingly questioned given the recent requirements of ISO 10993-1: Biological evaluation of medical devices; Part 1 – Evaluation and testing within a risk management process. This is in part due to the requirement set forth within ISO 10993-1 that indicates medical device manufacturers go beyond the minimalistic process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety.

      This webinar, presented by Don Pohl (Manager of U.S. Biological Safety & Validation Services, NAMSA), will take a look at the basic requirements of ISO 10993-1 and how device organizations can effectively identify processes to meet regulatory standard for multiple regulatory bodies.

      Questions to be addressed include:

      • What tools are available to device manufacturers to help identify an appropriate testing strategy?
      • How does chemical characterization testing fit into an overall biological evaluation plan? 
      • When are specific tests unnecessary, and what determines this?
      • Does a “check box” approach still guarantee regulatory approval?

      Time will also be allotted for Q&A.

      Moderator: Carl Swanson, Marketing Product Manager, NAMSA
      Presenter: Don Pohl, Manager, Biological Safety and Validation Services, NAMSA

      After registering, you will receive a confirmation email containing information about joining the webinar.

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      12:00 pm
      MassMEDIC Webinar: ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices
  2. Dec
    5
    Tue

    1. Webinar: Cyber Exposure and Medical Manufacturing Mitigating Risk
      10:00 am – 11:30 am

      MassMEDIC and Sylvia Group invite you to join us on Tuesday, December 5, as two nationally recognized experts —Charles Bellingrath of ARC Excess and Surplus, LLC, and John Mullen, privacy breach counsel from Mullen Coughlin  for a webinar on liabilities related to cyber, privacy and security exposures in the medical device industry.

      Click here for more information and to register

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      10:00 am
      Webinar: Cyber Exposure and Medical Manufacturing Mitigating Risk
  3. Dec
    6
    Wed

    1. MassMEDIC Webinar: Medical Device Single Audit Program (MDSAP): Can I really get down to just one audit? And how?
      12:00 pm – 1:00 pm

      Register for free here.

      MDSAP can potentially offer a variety of important advantages. While currently optional to replace FDA routine inspections, it will replace CMDCAS for Health Canada on January 1, 2019. Times will be busy with limited qualified auditing organizations alongside the transition to ISO 13485:2016 by March 2019, and EU MDR by May 2020. Attend this webinar if you want to understand MDSAP inside and out and be sufficiently prepared. Successful experiences will be shared along with step-by-step practical advice on how to prepare for your MDSAP audit. Real-world case studies will provide engaging examples of what to do and how to accomplish it.

      Presenter: Mark Swanson, Executive Director, Intelligence and Technical Excellence – Regulatory and Quality Solutions (R&Q)

      After registering, you will receive a confirmation email containing information about joining the webinar.

      +
      12:00 pm
      MassMEDIC Webinar: Medical Device Single Audit Program (MDSAP): Can I really get down to just one audit? And how?
  4. Dec
    8
    Fri

    1. MassMEDIC Webinar: You’ve Got IP Questions, MassMEDIC Has Answers – A Q&A with Neil Ferraro and A.J. Tibbetts, Patent Attorneys, Wolf Greenfield
      12:00 pm – 1:00 pm

      Register for free here.

      MassMEDIC is pleased to partner with Wolf Greenfield and provide you with a unique opportunity to interact and learn from two Intellectual Property experts.

      Here’s how this webinar will work: You register and join us online for the program on December 8. Using the online screen instructions, you pose your medtech IP question, anonymously, and our two experts will do their best to answer you.

      This “office hours” format worked well for the 200+ registrants we hosted at a similarly designed webinar in September. Attendees posed FDA regulatory questions to our expert, and we covered a range of issues in the hour-long session.

      Join us on December 8th and get to the bottom of your IP concerns!

       

      IP Experts

      Neil Ferraro

      A.J. Tibbets

      After registering, you will receive a confirmation email containing information about joining the webinar.

      +
      12:00 pm
      MassMEDIC Webinar: You’ve Got IP Questions, MassMEDIC Has Answers – A Q&A with Neil Ferraro and A.J. Tibbetts, Patent Attorneys, Wolf Greenfield
  5. Dec
    12
    Tue

    1. Register
      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

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

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