by Emily Sparrow | Nov 18, 2015
The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) released new data stating that the number of quality systems surveillance inspections for foreign manufacturers increased by 30%, despite the minor overall growth from 2013...
by Emily Sparrow | Nov 11, 2015
According to Zachary Brennan, within the next four years, the International Medical Device Regulators Forum (IMDRF) will be focusing its efforts on pre-market review and post-market surveillance. IMDRF is made up of regulators from Australia, Brazil, Canada, China,...
by Emily Sparrow | Nov 11, 2015
Our new eQMS service provider partner, greenlight.guru, recently published a guide on risk management for medical device companies. The guide establishes seven stages that are essential to the risk management process: risk management planning, risk analysis,...
by Emily Sparrow | Nov 11, 2015
FDA is contemplating the exemption of specific genetic screening systems that would test parents for conditions that they may pass down to their children; however, FDA states that not all autosomal recessive carrier screening gene mutation detection systems will be...
by Emily Sparrow | Nov 9, 2015
Pearl Pathways is looking forward to a new partnership with greenlight.guru, an eQMS service provider in Indianapolis, IN. This collaboration will provide clients a better way to navigate regulatory hurdles, shorten time to market, and reduce risk. Diana Caldwell,...
