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

AssurX Blog

Straight talk for regulated industries.

2708, 2019

Validation of a regulated computer system – what’s the big deal?

August 27th, 2019|Manufacturing Industries, Quality Management, Regulatory Compliance Management, Uncategorized|

Anyone who has been part of a successful validation effort for a regulated computer system (IT system) should consider themselves lucky souls. Throughout my own personal development, t [...]

1508, 2019

EU MDR Compliance: An Opportunity for Change

August 15th, 2019|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Uncategorized|

EU MDR Compliance: The new European device regulation will bring about impactful change. It is designed to do so. Since the 1990s, medical device regulation in Europe has been relative [...]

808, 2019

AssurX NERC Compliance Expert Kathryn Wagner Invited to Speak at 15th Annual EnergySec Security & Compliance Summit

August 8th, 2019|AssurX News + Success Stories, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management, Risk Management|

Will Host Breakout Session on NERC Compliance on Monday, August 19, 2019 Morgan Hill, CA., August 7, 2019 -- AssurX, Inc. (AssurX), a leader in quality management and regulatory compli [...]

907, 2019

AssurX Announces Patch Management Software for Greater IT and OT Asset Cybersecurity Control

July 9th, 2019|AssurX News + Success Stories, Energy & Utilities Industry, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, NERC Compliance, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Process-based Patch Management solution turns awareness into action Morgan Hill, CA., July 9, 2019 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance s [...]

2506, 2019

EU MDR Rules Could Impact Medical Device Business Strategies

June 25th, 2019|FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Changes in the European Union (EU) MDR and IVDR standards could force business change in the EU’s MedTech market. The second-largest market for medical devices is about to go through a [...]

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