Risk Management Software by AssurX

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.

How Risk-Based Testing is Revolutionizing Computer System Validation
How Risk-Based Testing is Revolutionizing Computer System Validation

How Risk-Based Testing is Revolutionizing Computer System Validation

AssurX Blog2024-01-13T02:37:12+00:00June 1st, 2020|

We live in a world where speed is vital to success. Patients and consumers expec [...]

Human Error is a Precipitator for Root Cause Analysis, Not Blame
Human Error is a Precipitator for Root Cause Analysis, Not Blame

Human Error is a Precipitator for Root Cause Analysis, Not Blame

AssurX Blog2024-06-03T13:33:05+00:00February 21st, 2020|

Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]

Take Action for ISO 13485:2016 Certification Preparedness
Take Action for ISO 13485:2016 Certification Preparedness

Take Action for ISO 13485:2016 Certification Preparedness

Sal Lucido2017-10-03T10:29:52+00:00October 3rd, 2017|

ISO 13485 has undergone its first major overhaul of manufacturing system require [...]

Risk Management Best Practices for Cybersecurity Compliance
Risk Management Best Practices for Cybersecurity Compliance

Risk Management Best Practices for Cybersecurity Compliance

AssurX Blog2017-01-30T01:59:17+00:00January 30th, 2017|

A new FDA guidance concerning risk management helps medical device manufacturers [...]

Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk Management + Quality Metrics Reporting: Revised FDA Guidance

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

AssurX Blog2017-01-16T12:48:28+00:00January 16th, 2017|

Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]

Part I: Enterprise Quality Management System Selection Best Practices

AssurX Blog2016-12-31T09:58:14+00:00December 31st, 2016|

Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

AssurX Blog2016-12-14T15:08:22+00:00December 14th, 2016|

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.

Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach
Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach

Utility NERC Compliance Programs Challenged by NERC’s New Risk-Based Approach

AssurX Blog2025-10-02T21:43:40+00:00November 30th, 2016|

If compliance with the North American Reliability Corporation (NERC) Reliability [...]

Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid
Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid

Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid

AssurX Blog2024-07-16T21:25:57+00:00October 24th, 2016|

Still think all of those concerns about cybersecurity protections on the electric grid are overblown? Try asking the 225,000 people in the Ukraine whose power was cut last December by a Russian hacking group that calls itself "Sandworm."

Cybersecurity – A Real Threat to Medical Devices

AssurX Blog2015-08-11T09:52:05+00:00August 11th, 2015|

The FDA just issued a Safety Communication on cybersecurity vulnerabilities of t [...]

Risk Management software