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.
Sign up now to take away some really valuable information in this fast moving industry.
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.