Blog2025-03-18T10:11:14+00:00

AssurX Blog

Straight talk for regulated industries.

1309, 2019

AssurX Demonstrating Regulatory & Quality Management Solutions at 2019 RAPS Conference

September 13th, 2019|AssurX News + Success Stories, Document Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Next week, AssurX will be exhibiting at the annual Regulatory Affairs Professionals Society (RAPS) Convergence Conference 2019 in Philadelphia.  RAPS is the largest global organization [...]

409, 2019

Cybersecurity for Medical Devices – Who’s Accountable?

September 4th, 2019|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Cybersecurity for Medical Devices is on the agenda for the U.S. Food and Drug Administration (FDA) September 10, 2019:  Patient Engagement Advisory Committee.  PEAC will be discussing [...]

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 [...]

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