AssurX’s FDA Compliance Software automates quality management processes, ensuring adherence to FDA regulations like 21 CFR Part 11. Our platform integrates with enterprise systems, enhancing visibility and control over compliance activities. Experience streamlined workflows and real-time insights to maintain high compliance standards.
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
In the life science industry, adjustments are a necessary element throughout the [...]
Unplanned downtime is an expensive issue, costing companies $50 billion every ye [...]
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen [...]
This is the second installment of a two-part series focusing on the importance [...]
This is the first installment of a two-part series focusing on the importance of [...]
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters [...]
As we move through 2022, we look forward to new opportunities, new challenges, a [...]
ABOUT
QUALITY AND COMPLIANCE SYSTEMS
FOR EVERY ENTERPRISE
SOLUTIONS
INDUSTRIES
CONTACT US
FOLLOW US
Sign up for the latest news and updates.
© Copyright 2000 - 2025, AssurX, Inc. All Rights Reserved.
