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Standards Development

IEC 60601-1, 3rd ed. + A2 Anticipated ’19 – Annual Standards Trends Reports Web Special

IEC 60601-1, 3rd ed. + A2 Anticipated ’19 – Annual Standards Trends Reports Web Special

Updated April 30 to extend Web Special til end of May ’17 (Note this service is not offered anymore please contact us with your questions.) Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC

leoeisner March 20, 2017June 12, 2022 Uncategorized Read more

New BSI Standards Development website

New BSI Standards Development website (source BSI Quality Management Newsletter Feb 2010) Search through standards currently in development and monitor their progress Discover and comment on proposals for new standards and draft standards Find out which trade associations and professional

leoeisner February 26, 2010 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

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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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