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.
Companies marketing devices in the European Union are facing a perfect storm of [...]
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
Software validation is historically one of the most difficult compliance activit [...]
As innovation in medical technology increases, potential cybersecurity threats a [...]
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
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 [...]
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