Skip to content
Eisner Safety Consultants

Eisner Safety Consultants

Just another WordPress site

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

Vigilance

MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System Updated to Rev 8

This blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.  The revised guidance is applicable as of July

leoeisner April 27, 2013 Uncategorized Read more

EC asks for further scientific study & draws 1st lessons from recent fraud on breast implants

From the Europa website the following press release was issued on 2 Feb 2012. The complete press release is below.  The original press release may be viewed too. European Commission – Press release Medical devices: European Commission asks for further

leoeisner February 3, 2012 Uncategorized No Comments Read more

UK MHRA Revamped Website!

The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a

leoeisner January 18, 2012 Uncategorized Read more

Eisner Safety Consultants Newsletter #2 Available

ESC Newsletter #2 – Just Released This issue we are focusing on the MDD Amendment 2007/47/EC including our toolkit to make your transition much easier and an interpretative EC guidance on the implementation of 2007/47/EC.  These are both great resources

leoeisner October 5, 2009 Uncategorized Read more

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

  • 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
  • IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech
    September 30, 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