Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium

Community

Start a Discussion
    • Newest
    • Most views
    Question
    Michael Weiner
    Chairman
    July 2016
    Alzheimer's therapy available in human trials - needs investors for expanded clinical trials & FDA approval
    Many available sources of light therapy will deter the degeneration of Alzheimer's and TBI, non-invasively. However, until someone large enough to afford FDA approval undertakes the initiative, the tragic onslaught of dementia will continue. This vid...
    Erik Vollebregt
    Partner at Axon Lawyers
    June 2016
    Transparency under the new MDR and IVDR
    With the new EU Medical Devices Regulation and IVD Regulation more or less established now, let's take a look at the transparency requirements under these regulations. This presentation was delivered at Informa's MedTech Summit in Brussels on 14 June...
    Eric Krohn
    Research Foundation for SUNY @ Koffman Southern Tier Incubator
    June 2016
    I am looking for help in obtaining CE certification, we are a philanthropic medical device start-up...working to end the transfer of Hep C and HIV among IV drug users.
    source: https://www.linkedin.com/groups/78665/78665-6146716667671044098
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2016
    Biocompatibility testing approach
    As originally asked by
    Kaushik Lodh
    Senior Vice President of Quality, O** Baby Care, Utah, USA
    October 2014
    Need help! How to get people motivated to follow regulatory compliance
    I am working with a start up, young energetic crowd, towards developing a new medical device. First version is off-the shelf monitor, not going for FDA approval. But later versions will aim for it. Nonetheless, it is to be used for monitoring infant ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2014
    Will Split Predicate Rule Delay Your Launch?
    FDA issued "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" this week. Group member Glenda Guest included the link at http://bit.ly/split-predicate and began a discussion about it. Among the changes are gui...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    October 2013
    Is there any requirement to list the ASTM or ISO material standard in the IFU?
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    September 2013
    510K VS PMA
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    February 2013
    Home Use Medical Device Initiative
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2013
    ISO 13485 Certification registrar and NB fees and approval time
    As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
    « Previous 1 2

      Stay connected with us.

      By signing up you are agreeing to our Privacy Policy.

      Categories

      • Capital/Investment
        • Business Model
        • Funding
      • Careers
      • Design/Devel
        • Design
        • Development
        • Human Factors
        • Labeling
        • Material Selection
        • R&D
        • Trials and Post-Market
      • Featured
      • Industry
        • Announcements
        • Device Tax
        • Hospital and Health Care
        • Innovation
        • Medtech
      • LinkedIn, etc.
      • Markets
        • Africa
        • Americas
        • Asia
        • Australia
        • Europe
      • Regulating
        • CE Marking
        • EU
        • FDA
        • FDA/EU etc.
        • Notified Bodies
        • Quality
        • Regulatory
      • Selling
        • Distribution
        • Intellectual Property
        • Marketing/Sales
        • Reimbursement
      • Worth bookmarking!
      Featured Job

      You Won’t Want to Miss a Thing.

      We’re working to make MedicalDevicesGroup.net the world’s most useful site to serve the medical device industry.

      By signing up you are agreeing to our Privacy Policy.

      logo

      Companion to LinkedIn's 350,000 member community

      • Contact
      • Medical Device Marketing
      • In Memoriam
      • Medical Device Conference

      The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

      Medical Devices Group
      Powered by  GDPR Cookie Compliance
      Privacy Overview

      This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

      Strictly Necessary Cookies

      Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

      If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.