The Regulation of Wearable Medical Devices.

This article provides a guideline for the design, manufacture, regulatory approval, and post-market surveillance (PMS) of wearable medical devices (WMDs). The integration of regulatory considerations can accelerate wearable device (WD) development from laboratory to market while mitigating device failure risks. The implementation of stringent clinical evaluations will transcend WDs beyond consumer products. PMID: 31320119 [PubMed - as supplied by publisher]
Source: Trends in Biotechnology - Category: Biotechnology Authors: Tags: Trends Biotechnol Source Type: research