Wearable medical products have granted users a new awareness of how their everyday activities affect their overall health. They gain visibility int [...]
The U.S. Food and Drug Administration strives to ensure that all approved or cleared medical devices are safe for patients. Providing evidence that new [...]
The medical device development process has many important differences from the path for creating a new drug. In regulating new prod [...]
MPE (Formerly Mindflow Design) has not renewed ISO 9001 certification and continues to be certified through ISO 13485.
MPE (Formerly Mindflow Design) , a leading product developer for medical, life sciences and consumer health companies, has earned ISO 900 [...]
[vc_row][vc_column][vc_column_text]MPE (Formerly Mindflow Design) has not renewed ISO 9001 certification and continues to be certified through ISO 13485.
Submitting innovative medical products to the U.S. Food and Drug Administration Center for Devices and Radiological Health is a complex and len [...]
[vc_row][vc_column][vc_column_text]The medical device and consumer product worlds have collided. We saw evidence of this recently at the
On January 18 2017, the U.S. Food and Drug Administration released a pair of draft guidances on medical product communications. These rules could have significant implications for the ways manufacturers present
There are numerous promising signs for the use of innovative products in mobile health. From scientific research out of Stanford Un [...]
Users monitor their own health and fitness every day with wearable devices, collecting a variety of data on their vital signs and activities. Now, it seems that information may be able to accomplish far more than helping exercise buffs set goals for their next [...]
A study from eMarketer predicted that 39.5 million American adults will use wearable devices on a monthly basis in 2017. The data emergin [...]
Digital health products that track physical activity levels, heart rates and other relevant data can assist people of all ages and lifestyles in maintaining their well-being. However, as a study in Health Affairs noted, there's still much work to be done in [...]
On December 12, 2016, four organizations announced the beginning of a collaboration intended to develop and promote best practices for digital health apps. The nonprofit corporation, called Xcertia, was officially unveiled at the Connected Health Conference hel [...]
The market for wearable technology continues to grow and change as consumers find useful ways to incorporate these products into their lifestyles. According to International Data Corporation, total shipments of wearable devices