Quality Management

The “Quality Management” category at AssurX provides a comprehensive look into effective strategies and tools for optimizing quality processes. This section covers essential topics such as process improvement, compliance integration, and performance measurement. By leveraging these resources, organizations can enhance their quality management systems, ensuring consistent product quality and operational efficiency. AssurX offers the expertise and solutions necessary to drive continuous improvement and maintain high standards across industries.

23 06, 2022

AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry
AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry

AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry

By Tracy Orlick|2025-10-03T04:02:53+00:00June 23rd, 2022|AssurX News + Success Stories, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality man [...]

21 06, 2022

5 Ways an EQMS Resolves Change Management and Change Control Pains
5 Ways an EQMS Resolves Change Management and Change Control Pains

5 Ways an EQMS Resolves Change Management and Change Control Pains

By Sal Lucido|2024-06-03T13:58:34+00:00June 21st, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In the life science industry, adjustments are a necessary element throughout the [...]

14 06, 2022

Why Calibration Management Software is Key to Proactive Quality
Why Calibration Management Software is Key to Proactive Quality

Why Calibration Management Software is Key to Proactive Quality

By Sal Lucido|2024-03-12T13:29:17+00:00June 14th, 2022|Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Unplanned downtime is an expensive issue, costing companies $50 billion every ye [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation Still Presents Challenges and Opportunities

EU Medical Device Regulation Still Presents Challenges and Opportunities

By Sal Lucido|2024-12-31T23:16:11+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

17 05, 2022

Food Industry FSVP Violations Revealed in FDA Warning Letters
Food Industry FSVP Violations Revealed in FDA Warning Letters

Food Industry FSVP Violations Revealed in FDA Warning Letters

By Sal Lucido|2024-06-25T18:25:29+00:00May 17th, 2022|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen [...]

5 05, 2022

How to Overcome Quality Management Review Challenges
How to Overcome Quality Management Review Challenges

How to Overcome Quality Management Review Challenges

By AssurX Blog|2025-01-10T20:52:36+00:00May 5th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

This is the second installment of a two-part series focusing on the importance [...]

28 04, 2022

What is a Quality Management Review and Why Do You Need Them?
What is a Quality Management Review and Why Do You Need Them?

What is a Quality Management Review and Why Do You Need Them?

By AssurX Blog|2024-03-26T20:17:31+00:00April 28th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

This is the first installment of a two-part series focusing on the importance of [...]

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation
Understanding FDA Alignment of ISO 13485 with Quality System Regulation

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By AssurX Blog|2024-03-04T21:30:05+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

7 04, 2022

FDA Warning Letters Highlight Food Safety Compliance Issues
FDA Warning Letters Highlight Food Safety Compliance Issues

FDA Warning Letters Highlight Food Safety Compliance Issues

By AssurX Blog|2025-10-03T04:05:48+00:00April 7th, 2022|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management|

The U.S. Food and Drug Administration (FDA) has issued dozens of warning letter [...]

31 03, 2022

miraDry Implements AssurX Quality Management and Regulatory Compliance Software
miraDry Implements AssurX Quality Management and Regulatory Compliance Software

miraDry Implements AssurX Quality Management and Regulatory Compliance Software

By Tracy Orlick|2025-10-03T04:17:01+00:00March 31st, 2022|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leade [...]