Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

17 06, 2025

QMS Software: When to Configure and When to Customize

By |2025-06-17T15:25:23+00:00June 17th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

When it comes to managing quality and compliance in today’s regulated industries [...]

21 05, 2025

Human Factors in CAPA Part III: How To Secure Management Commitment

By |2025-05-21T13:32:55+00:00May 21st, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In the third and final part of our Human Factors in CAPA series, we’re tackling [...]

14 05, 2025

Human Factors in CAPA Part II: How to Improve CAPA Accountability

By |2025-05-19T18:44:35+00:00May 14th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In Part I of our Human Factors in CAPA series, we talked about employee engagem [...]

7 05, 2025

Human Factors in CAPA Part I: How to Improve Employee Engagement

By |2025-05-07T15:05:26+00:00May 7th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

At its core, corrective and preventive action (CAPA) is about systematically ev [...]

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 |2025-05-07T15:08:38+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 [...]

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