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Regulatory & Safety Experts for Global Medical Device Approvals

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Wearable

Welcome Mary Weick-Brady to Eisner Safety Consultants

I am thrilled to announce our latest addition to the Eisner Safety Consultants team Mary Weick-Brady recently joined our team and will help us support a growing need for the Wearable Medical Devices and the Home Use Medical Markets. Ms. Weick-Brady comes with

leoeisner September 29, 2015 Uncategorized Read more

Back by Popular Demand – Wearable Medical Devices – FDA’s Current Thinking

As this presentation was so well attended in July FX Conferences has decided to rerun this presentation twice in August so those that missed it can obtain this critical information for the Wearable Medical Device industry.  Leo Eisner will be

leoeisner July 29, 2015 Uncategorized Read more

Presentation on Wearable Medical Devices – Current Thinking from FDA

Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices.  This presentation is being offered 2 times in July (Tuesday July

leoeisner July 7, 2015 Uncategorized Read more

Part 2 – Wearables the rage but are they medical devices?

Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more From the previous “Wearables the rage but are they medical devices?” blog post I indicated

leoeisner April 30, 2015 Uncategorized Read more

510(k) Workshop at 10X Conference

On May 4, 2015 in San Diego, I, Leo Eisner, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference is from May 4 – 6, 2015 at the Hilton San Diego Mission

leoeisner April 17, 2015 Uncategorized Read more
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Recent Industry News

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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

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