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.