Skip to content
Eisner Safety Consultants

Eisner Safety Consultants

Regulatory & Safety Experts for Global Medical Device Approvals

Menu

  • HOME
  • ABOUT US
    • ESC EXPERTS & ASSOCIATES
    • ESC Partners
    • ESC Affiliates
  • BLOG
  • SPECIALIZED SERVICES
  • SCHEDULE MEETING
  • RESOURCES
    • CURRENT IEC 60601/80601 STANDARDS
    • DRAFT IEC 60601/80601 STANDARDS
    • ARCHIVES
      • ARCHIVE PUBLICATIONS
      • Isolation/Insulation Diagrams
  • CONTACT

FDA Third Party Review

FDA Weighing Future of Third-P…

FDA Weighing Future of Third-Party Device Review http://ow.ly/1o28W

eisnersafety March 18, 2010 Uncategorized Read more

Recent Industry News

  • IEC 60601, 4th Edition: What’s Changing and How to Prepare
    February 28, 2026
  • Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards
    January 4, 2026
  • Medical Device Compliance & Certification Summit – Why It Matters?
    December 23, 2025
  • What’s NASA & Star Trek have to do with IEC 60601?
    November 29, 2025
  • From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast
    October 19, 2025

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 IEC60601-1 IEC 60601-1 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

Newsletter Sign-up

Join Our Newsletter

Eisner Safety Consultants will use the information you provide on this form to be in touch with you and to provide updates and marketing. Please let us know you would like to hear from us by e-mail:

You can change your mind at any time by clicking the unsubscribe link in the footer of any email you receive from us, or by contacting us at . We will treat your information with respect. For more information about our privacy practices please visit our website. By clicking below, you agree that we may process your information in accordance with these terms.

We use Mailchimp as our marketing platform. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Learn more about Mailchimp's privacy practices.

Recent Industry News

  • IEC 60601, 4th Edition: What’s Changing and How to Prepare
    February 28, 2026
  • Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards
    January 4, 2026
  • Medical Device Compliance & Certification Summit – Why It Matters?
    December 23, 2025
  • What’s NASA & Star Trek have to do with IEC 60601?
    November 29, 2025
  • From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast
    October 19, 2025

Links and Resources

  • Our Profile
  • Our Associates
  • Our Specialized Service
  • Archive Publications
  • Current IEC 60601-1 Standards
  • Draft IEC 60601-1 Based Standards
  • Blog (Industry News)
  • Resources

Contact Us

  • Address
  • 2866 NW Fairfax Terrace
  • Portland, OR 97210
  • Email: Leo at EisnerSafety dot com
  • Website: Eisner at EisnerSafety dot com
Copyright © 1999 - 2026 Eisner Safety Consultants. Designed by Tania Avanzi, ClubWeb. All rights reserved. Theme base Spacious by ThemeGrill. Powered by WordPress.
  • Industry News