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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

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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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  • Portland, OR 97210
  • Email: Leo at EisnerSafety dot com
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