EU MDR vs. U.S. QSR and the Role of Digitization

By Jason Jegge, Quality and Regulatory Consultant, MWA Consulting, Inc The differences in the ways medical devices are regulated in the U.S. and Europe are subtle but important to understand. This article examines those differences and explains how digitization...

Conducting Remote GxP Audits: Three Keys to Success

By Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting, Inc. Introduction The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on...