AssurX Risk Management Software enhances the identification, assessment, and control of risks across enterprises. Our platform integrates with quality management systems to automate risk processes, ensuring compliance with standards like ISO 14971 and ISO 9001. Experience improved visibility and decision-making with real-time risk analysis and reporting.
Regulators and standards organizations are increasingly requiring manufacturers [...]
Part 2 of a three-part EQMS blog series If you’re responsible for establishing [...]
There’s no question that quality risk management is becoming an indispensable to [...]
We live in a world where speed is vital to success. Patients and consumers expec [...]
Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]
ISO 13485 has undergone its first major overhaul of manufacturing system require [...]
A new FDA guidance concerning risk management helps medical device manufacturers [...]
Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]
Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.
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