Wearable Medical Device – Eisner Safety Consultants

Welcome Mary Weick-Brady to Eisner Safety Consultants

leoeisner — Tue, 29 Sep 2015 05:49:46 +0000

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 tremendous experience in the Home Use space and with respect to patient labeling and will be a fantastic addition to our company. With 25 years of experience at the FDA, and over 30 years of experience as a registered nurse, including 6 years as a home health care nurse, Ms. Weick-Brady is able to provide training on home use policy, assist with premarket submissions intended for home use, and help industry understand the regulatory process. As Mary & I were talking about her joining the Eisner Safety Consultants team her excitment to help with the Home Use market and users of these devices seemed endless. She made a point that she is concerned for the end user, particularly the patient. This is clear by her statement to me: “I am (Mary) invested in having an understandable format of instructions for use and to make sure these instructions for use are accessible and usable by the end user. She is also invested in making sure medical devices are being developed with the end user in mind as a useful and usable part of healthcare in non-clinical environments.”

Please welcome Mary Weick-Brady to our growing team that can support your medical device policy, regulatory, safety certification, and quality system needs. To find out more about her background and the rest of the Eisner Safety Consultants team members please check out our Associates web page.

If you need additional support for Wearable Medical Devices and Home Use Medical Devices email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

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

leoeisner — Wed, 29 Jul 2015 18:39:42 +0000

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 speaking on Medical Device Wearables & FDA’s Current Thinking with respect to a slew of new guidance documents that could apply to your devices. This presentation is being offered 2 times in August (Tuesday August 11, 9:30AM Eastern and Wednesday August 12, 2:00PM Eastern). No travel required to go to this presentation just dial in, download the material & you’re set to learn from Leo Eisner, an industry expert. Receive a $50.00 (US$) discount as a special thank you for visiting us at Eisner Safety Consultants (See below).

What’s it about: The presentation guides you through many significant issues concerning the design & development of wearable medical devices. Leo will provides an in-depth look at the FDA guidance documents that may apply to your wearables, including the Home Use Environment, Mobile Medical Applications, Accessories, and General Wellness guidances among additional broader based ones.

Join us for this audio conference presentation and bring your group up to speed as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

Does the FDA consider your wearable a medical device?
FDA’s Final Guidances on Mobile Medical Applications & Home Use Environment
The differences between the IEC & AAMI Home Use Environment Medical Electrical Equipment and Systems Standard (60601-1-11) and it’s impact on the FDA Home Use Guidance
Draft General Wellness & Accessories Guidances
Additional Regulations that may impact your Wearable device beyond the FDA

Click here for the details on the presentation & discount ($50.00 off regular price) and also some other past presentations from FX Conferences that we have presented.

Presentation on Wearable Medical Devices – Current Thinking from FDA

leoeisner — Tue, 07 Jul 2015 05:24:25 +0000

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 21, 10:00AM Eastern and Thursday July 23, 1:00PM Eastern). The best thing is you don’t have to travel to go to this presentation just dial in, download the material and you are set to learn from an industry expert. As a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 (US$) discount.

What’s it about: This audio conference presentation guides attendees through many of the significant issues concerning the development of wearable medical devices. Leo provides an in-depth look at the guidance documents that may apply to your wearables, including the Mobile Medical Applications, Home Use Environment, General Wellness, and Accessories guidances among additional broader based ones.

Join us for this audio conference presentation and ease your regulatory stress as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device. This audio conference will cover:

Is your wearable a medical device per the FDA?
FDA’s Final Mobile Medical Applications & Home Use Environment Guidances
The differences between the IEC & AAMI versions of 60601-1-11 (Home Use Environment Medical Electrical Equipment and Systems) Standard and how it impacts your use of the Home Use Guidance
Draft General Wellness & Accessories Guidances
Other Regulations that can apply to Wearables outside of FDA
Understanding which Recognized Consensus Standards may apply to your device

To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.