Blog2022-01-15T20:42:38+00:00

AssurX Blog

Straight talk for regulated industries.

2003, 2019

What to Make of FDA’s Secret Cache of Device Adverse Events

March 20th, 2019|FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Last week an investigative report revealed the FDA has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, [...]

1803, 2019

American Society for Quality (ASQ) CEO to Talk About Achieving a Culture of Quality at Upcoming User Conference

March 18th, 2019|AssurX News + Success Stories, Quality Management|

The same principles and tools that produce an effective military culture can be applied to organizations seeking a successful culture of quality, according to ASQ CEO and retired Three [...]

2002, 2019

NERC CIP Violations are a Lesson in Management and Modernization

February 20th, 2019|Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management, Risk Management|

The recent Notice of Penalty and Enforcement Action of $10M to a Registered Entity (RE) for 127 NERC CIP violations demonstrates that the cost of non-compliance far exceeds the cost of [...]

2011, 2018

Keeping your Enterprise QMS Implementation Project on Schedule

November 20th, 2018|Quality Management, Regulatory Compliance Management|

Due dates. Everyone has them, everyone wants them. Whether it’s building a house or implementing an Enterprise Quality Management Software (QMS) solution. What does home construction h [...]

708, 2018

AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation

August 7th, 2018|FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

Morgan Hill, CA – August 8, 2018 - AssurX,Inc. (AssurX), a leading provider of enterprise quality management and regulatory compliance software, today announced the recent completion o [...]

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