Enterprise Quality Management System (EQMS)

27 04, 2023

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

By |2023-04-27T17:53:40+00:00April 27th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]

25 08, 2022

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

By |2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Companies marketing devices in the European Union are facing a perfect storm of [...]

20 07, 2022

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

By |2022-07-20T07:00:42+00:00July 20th, 2022|Document Management, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

As innovation in medical technology increases, potential cybersecurity threats a [...]

13 07, 2022

QMS Configuration vs. Out-of-the-Box: Real-World Considerations

By |2022-07-13T08:23:37+00:00July 13th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

When evaluating an automated QMS, the question to invest in configuration vs. ou [...]

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