August 22, 2019
By David Butcher, Staff Writer, MasterControl,Pete Raghubans, Quality Assurance Manager, EpiBone, and Julia Porrino, Quality Assurance Specialist, EpiBone
In this Q&A, EpiBone’s quality assurance manager and quality assurance specialist explain why and how the Brooklyn-based regenerative medicine company chose to digitize and automate their production records with MasterControl’s Manufacturing Excellence solution.
February 9, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .
January 4, 2018
By Mike Rigert, Staff Writer, MasterControl
A little over a year ago, the U.S. Federal Drug Administration (FDA) released its draft guidance (1) regarding a newer, skyrocketing segment of the medical device industry—that of Software as a Medical Device (SaMD). The guidance means to address the emergence of thousands of stand-alone, health-oriented software apps that fall into a gray area in terms of regulation. Obviously, SaMDs aren’t traditional medical devices, but neither are they Pokémon Go.
