Achieving Global Approvals for mHealth Devices and Products

//Achieving Global Approvals for mHealth Devices and Products
Achieving Global Approvals for mHealth Devices and Products 2017-12-22T00:05:22+00:00

Project Description

The adaptation of wireless technologies is a key element in the overall effort by healthcare providers and caregivers to increase access to services, improve patient outcomes, control costs and provide patients with greater mobility.

As such, mobile medical technologies represent a clear and significant opportunity for manufacturers seeking to provide products and services to an increasingly dynamic and complex healthcare marketplace. Indeed, the global market for wireless health technologies is projected to reach more than $38.5 billion by 2016, representing an average annual growth of nearly 20%. Despite their growing use in healthcare settings, however, mobile technologies present a number of unique safety and security concerns that go beyond those found with similar devices used in other environments.

About UL White Papers

This UL white paper provides an overview of mHealth technologies and the regulatory requirements that manufacturers must address before bringing new mHealth devices to market. Beginning with a general background on mHealth technologies, the paper then discusses specific safety and security risks associated with their use. The white paper then provides a framework for the various technical issues associated with mHealth technologies, and discusses specific regulatory requirements in key markets around the world. The paper concludes with recommendations for manufacturers seeking global approval for mHealth technologies.

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