Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016.  I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding.  This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and other factors discussed in the article.

There is a huge need to support those at home that are sick, injured, has an acute issue or chronic illness that want a comfortable life and would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too.  I know I was ready to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting.  So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations.   One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices.  FDA has written guidances for both Home Use Medical Devices and Wellness Devices to clarify from their perspective.  There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and other IEC technical documents for home use medical devices and non-medical devices (Some being wellness devices).  The article goes into detail on this SyC AAL and also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.

Enjoy the article and if you have interest in or need help with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants.

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.

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.