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.

3 10, 2017

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

Take Action for ISO 13485:2016 Certification Preparedness

By Sal Lucido|2017-10-03T10:29:52+00:00October 3rd, 2017|FDA Regulated Industries, Regulatory Compliance Management, Risk Management|

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

30 01, 2017

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

Risk Management Best Practices for Cybersecurity Compliance

By AssurX Blog|2017-01-30T01:59:17+00:00January 30th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

16 01, 2017

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

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

By AssurX Blog|2017-01-16T12:48:28+00:00January 16th, 2017|Archives, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

31 12, 2016

Part I: Enterprise Quality Management System Selection Best Practices

By AssurX Blog|2016-12-31T09:58:14+00:00December 31st, 2016|Archives, Quality Management, Regulatory Compliance Management, Risk Management|

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

14 12, 2016

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

By AssurX Blog|2016-12-14T15:08:22+00:00December 14th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance Management, Risk Management|

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.

30 11, 2016

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

By AssurX Blog|2025-10-02T21:43:40+00:00November 30th, 2016|Archives, Energy & Utilities Industry, Risk Management|

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

24 10, 2016

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

By AssurX Blog|2024-07-16T21:25:57+00:00October 24th, 2016|Archives, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management, Risk Management|

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."

11 08, 2015

Cybersecurity – A Real Threat to Medical Devices

By AssurX Blog|2015-08-11T09:52:05+00:00August 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Risk Management|

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

4 06, 2015

Large Utilities Power Up with AssurX Enterprise GRC Solution

By Tamar June|2025-10-02T22:51:33+00:00June 4th, 2015|Archives, NERC Compliance, Regulatory Compliance Management, Risk Management|

Increasingly complicated, and disparate, regulatory requirements and a demand fo [...]

30 04, 2015

Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls

By AssurX Blog|2024-06-03T13:21:35+00:00April 30th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Risk Management|

IEC 62304, the international standard that defines software development lifecycl [...]

Risk Management software