Read the recent IEC e-tech magazine article (in Oct 2016 e-tech) titled ‘Rapid growth in home use of medical devices requires new standards‘.  It discusses both medical and non-medical home use devices and where standards development is going.  Also, it discusses wellness devices which can be a medical device or a non-medical device depending on its intended use, in some countries.

‘IEC work underpins fast growing support for home use of health and wellness devices’ – IEC e-tech article quote

Dexcom G5 Mobile is a compact continuous glucose monitoring (CGM) system that can provide accurate, real-time glucose readings every five minutes for people with type 1 or type 2 diabetes on mobile devices (Photo: Dexcom, Inc.)
Dexcom G5 Mobile is a compact continuous glucose monitoring (CGM) system that can provide accurate, real-time glucose readings every five minutes for people with type 1 or type 2 diabetes on mobile devices (Photo: Dexcom, Inc.)

IEC has published the above article that I originally wrote back in August 2016 (The above IEC article is written with a slightly different spin on it) for

InCompliance Aug 2016 Cover Pg
photo courtesy of In Compliance Magazine, Aug 2016

InCompliance Magazine titled “Home Use Medical and Wellness Devices”.
Both articles are worth a read as you will learn different information from each one.

I hope you enjoy the two articles and if there is anything I can answer please contact me at either Leo at EsnerSafety dot com or 503-244-6151.

Rapid Growth in Home Use of Medical Devices Requires New Standards