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in vitro diagnostics

EU MDR & IVDR Have Been Published in OJEU 5 May 2017

EU MDR & IVDR Have Been Published in OJEU 5 May 2017

Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were  Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or

leoeisner May 4, 2017June 12, 2022 EU, IVDR, May 2017, MDR, Medical Device Regulation, Notified Bodies Read more

Impact of the Draft report on the EU MDD proposed regulations

This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess

leoeisner April 30, 2013 Uncategorized Read more

Recent Posts

  • The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    September 30, 2024
  • Time and Regulators Wait for No One – Free Presentation

    Time and Regulators Wait for No One – Free Presentation

    September 28, 2024
  • What Standards Apply to My Device? Podcast #383

    What Standards Apply to My Device? Podcast #383

    September 25, 2024
  • Join Leo Eisner In The Next Let’s Talk Risk Episode

    Join Leo Eisner In The Next Let’s Talk Risk Episode

    August 30, 2024
  • Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

    Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

    August 29, 2024
  • How to ID Applicable Standards – Combinate Podcast

    How to ID Applicable Standards – Combinate Podcast

    August 7, 2024

Categories – Drop Down

Categories – Hot Topics

510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC 60601-1 IEC60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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Recent Industry News

  • The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    September 30, 2024
  • Time and Regulators Wait for No One – Free Presentation

    Time and Regulators Wait for No One – Free Presentation

    September 28, 2024
  • What Standards Apply to My Device? Podcast #383

    What Standards Apply to My Device? Podcast #383

    September 25, 2024
  • Join Leo Eisner In The Next Let’s Talk Risk Episode

    Join Leo Eisner In The Next Let’s Talk Risk Episode

    August 30, 2024
  • Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

    Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

    August 29, 2024

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