FDA Regulated Industries

The “FDA Regulated Industries” category at AssurX helps organizations meet the strict requirements of the U.S. Food and Drug Administration. This section offers insights into quality management, compliance strategies, and process optimization for FDA-regulated sectors. It covers topics like navigating complex regulations, ensuring product safety, and maintaining high quality. AssurX provides expertise to help professionals achieve compliance, boost efficiency, and drive innovation, ensuring products meet all regulatory requirements.

17 04, 2025

Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing

By |2025-04-17T12:50:31+00:00April 17th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Every day, quality leaders face a variety of production and process issues. Whi [...]

24 03, 2025

Understanding the Differences Between Deviation vs. Nonconformance

By |2025-04-04T02:10:09+00:00March 24th, 2025|Deviation, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The pharmaceutical industry and the medical device industry have unique ways of [...]

13 03, 2025

How to Use a Risk Matrix to Ensure Effective Risk Management

By |2025-03-18T08:54:55+00:00March 13th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In manufacturing and in life, we can never completely eliminate risk. What matt [...]

10 03, 2025

3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI

By |2025-03-18T08:55:18+00:00March 10th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring comp [...]

27 02, 2025

Enhancing Compliance Through Quality Risk Management 

By |2025-03-18T08:56:54+00:00February 27th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Quality risk management (QRM) has become a crucial tool for ensuring regulatory [...]

6 02, 2025

BPM Partners with AssurX to Enhance Cybersecurity and Compliance Solutions for Energy and Utility Industry

By |2025-03-18T08:57:38+00:00February 6th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

SAN FRANCISCO, Jan. 15, 2025 – BPM LLP, one of the 35 largest public accounting [...]

23 01, 2025

Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing

By |2025-04-04T02:25:48+00:00January 23rd, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

Risk mitigation is crucial for manufacturing quality products because it helps [...]

9 01, 2025

How to Achieve Manufacturing Quality Compliance Success: Apply Automation

By |2025-03-18T09:00:45+00:00January 9th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

FDA inspections and subsequent actions all come down to product quality. Qualit [...]

18 12, 2024

Overcoming the Challenges of Medical Device Complaint Handling with AI: How 3Analytics Leads the Way

By |2025-04-04T02:28:15+00:00December 18th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The medical device industry plays a pivotal role in global healthcare, deliveri [...]

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