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.

25 08, 2022

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

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

By Stephanie Ojeda|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 [...]

10 08, 2022

Overcoming Common Challenges of Customer Quality Complaint Handling
Overcoming Common Challenges of Customer Quality Complaint Handling

Overcoming Common Challenges of Customer Quality Complaint Handling

By Stephanie Ojeda|2022-08-10T07:42:52+00:00August 10th, 2022|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

From food and beverage to electronics to CPG, there’s not a single type of manuf [...]

3 08, 2022

Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety
Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety

Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety

By Stephanie Ojeda|2024-06-25T18:20:46+00:00August 3rd, 2022|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management|

From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]

26 07, 2022

How to Establish Sustainable Validation for FDA & EU Compliance
How to Establish Sustainable Validation for FDA & EU Compliance

How to Establish Sustainable Validation for FDA & EU Compliance

By Stephanie Ojeda|2023-09-07T22:44:48+00:00July 26th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Sustainable Validation|

Software validation is historically one of the most difficult compliance activit [...]

20 07, 2022

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

By Stephanie Ojeda|2024-12-31T23:16:44+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
QMS Configuration vs. Out-of-the-Box: Real-World Considerations

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

By Sal Lucido|2024-06-03T13:28:45+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 [...]

30 06, 2022

EUDAMED Update: What You Need to Know Now
EUDAMED Update: What You Need to Know Now

EUDAMED Update: What You Need to Know Now

By Sal Lucido|2022-06-30T21:11:53+00:00June 30th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]

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 [...]