Avoid QMS Implementation Failures with the Right Team
This blog it the first of a three-part series on QMS implementation best practices. Sign up for our blog to receive parts two and three. Even after decades of eQMS availability, a staggering number of [...]
5 Commonalities of Enterprise Supplier Quality Management Systems
Global-scale events have tested the bounds of a supply chain system. The coronavirus, for example, has made it clear how critical an efficient supply chain is for continuity and survival. It is a real [...]
Don’t take your foot off the gas on EU MDR implementation
The coronavirus has had a massive impact on the medical device industry. As a consequence, the European Commission has accepted a proposal to postpone the EU MDR application date. This may be a welco [...]
Human Error is a Precipitator for Root Cause Analysis, Not Blame
Have you ever been part of a process that had a failure or two? Perhaps you’ve been on a team that missed a deadline because something didn’t go as expected. Most of us have. In many cases, the team [...]
AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers
Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced the availability of its Manufacturing Incident Report (MIR) S [...]
AssurX EU MDR Webinar Follow-Up: 10 FAQs for Tackling EU MDR Data Management
Last month, AssurX hosted a webinar entitled “Who Moved my MDR? Assessing Organizational Readiness” with Richard Houlihan, CEO of Eudemed.eu and leading consultant and international speaker on MDR tec [...]
EU MDR Rules Could Impact Medical Device Business Strategies
Changes in the European Union (EU) MDR and IVDR standards could force business change in the EU’s MedTech market. The second-largest market for medical devices is about to go through a significant ove [...]
NERC to Expand CIP Reliability Standards
The Federal Energy Regulatory Commission (FERC) issued Order No. 848 on July 19, which instructs the North American Electric Reliability Corp. (NERC) to expand CIP reliability standards to include man [...]
NERC Reliability Standards Require Centralized Data Management
In a recent study of over 600 electric utility employers, 72% of professionals identified physical and cybersecurity as the most pressing issue for the sector in 2017. The study, published in State of [...]
Cloud for quality and compliance management: A primer for life sciences companies
Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.
