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  • Welcome
    We invite you to register and join this community of Medical Device Professionals in order gain knowledge, give knowledge, and collaborate in order to help reach solutions for the benefit of patients and medical professionals our industry serves. New members will immediately have access to all forums, topics, and discussions. We also have a jobs board for free postings of available jobs. For those job hunting, showcase your experience and availability.
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  • Community Rules
    These rules are disclosed to clarify the various responsibilities of all community members here on They have been compiled and are revised regularly by the Team. Please be mindful of the rules to help ensure a level of professionalism and respect for all members.
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    Last post by RegsMstr View the latest post
    Thu Mar 06, 2014 11:46 pm
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  • 21cfrHelp
    This forum is intended for collaboration, interpretation and guidance regarding the US Food and Drug Administration (FDA) Code of Federal Regulations (CFR).
    10 Topics
    14 Posts
    Last post by Mikerinc View the latest post
    Tue Jan 21, 2020 6:54 pm
  • 510kHelp
    This forum is intended for collaboration, interpretation and guidance regarding the US 510(k) process.
    2425 Topics
    48702 Posts
    Last post by vinson View the latest post
    Tue Feb 25, 2020 4:56 pm
  • MedDevHelp
    This forum is intended for collaboration, interpretation and guidance regarding other topics that may not fall directly under the 21CFR and 510k Forums. Such topics here could include International Regulatory Information, software, labeling, sterilization, packaging strategies.
    5 Topics
    11 Posts
    Last post by Smilteple View the latest post
    Tue Jan 07, 2020 4:27 am
  • Standards
    Forum for Discussing Key Standards
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  • Did you know?
    Have some interesting knowledge, technique, strategy, or tactic to share? Please share. For example......Did you know that if you are selling a replacement product in the EU, it does not need to be CE marked. To help it clear importing easier, make sure the product description includes the word "Replacement"? The CE mark conformance is satisfied by the CE mark of the original device that was placed on the European market.
    4 Topics
    4 Posts
    Last post by WendyG View the latest post
    Mon Dec 02, 2019 1:18 am
  • Jobs
    Forum for posting and seeking jobs. Once a job seeker or provider has posted a new topic, discussions / contacts may be initiated through public or private messaging.

    NOTE: Postings in this forum will be deleted by the system 90 days after the initial post.
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  • RICAS (Regulation Information, Changes, Alerts, & Strategies)
    This forum is intended for country specific regulation questions and discussions. Need strategy help? Heard about a new regulation change? Add it here! Help spread the word and generate discussion on the changes, interpretation, implementation dates and impact. PLEASE make sure to post the discussion in the correct country forum.
    Subforums: A - B, C - D, E - G, H - L, M - N, O - R, S - T, U - Z
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