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.

28 03, 2024

How EHS Software Solutions Can Revolutionize Workplace Safety
How EHS Software Solutions Can Revolutionize Workplace Safety

How EHS Software Solutions Can Revolutionize Workplace Safety

By Stephanie Ojeda|2025-03-18T09:26:26+00:00March 28th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

According to U.S. Bureau of Labor Statistics data, the number of preventable wor [...]

14 03, 2024

Real-Life Results from Implementing Compliance Management Systems
Real-Life Results from Implementing Compliance Management Systems

Real-Life Results from Implementing Compliance Management Systems

By Stephanie Ojeda|2025-03-18T09:27:12+00:00March 14th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Companies today implementing automated compliance management systems are motivat [...]

5 03, 2024

Top Considerations for Compliance Management Tools
Top Considerations for Compliance Management Tools

Top Considerations for Compliance Management Tools

By Stephanie Ojeda|2025-03-18T09:27:36+00:00March 5th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Implementing an automated compliance management solution is a mammoth undertakin [...]

22 02, 2024

Why Change Control is Important: Tips for Manufacturers
Why Change Control is Important: Tips for Manufacturers

Why Change Control is Important: Tips for Manufacturers

By Stephanie Ojeda|2025-03-18T09:27:45+00:00February 22nd, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Change is a constant in manufacturing, and is both necessary for innovation and [...]

30 01, 2024

The Hidden ROI of Complaint Management
The Hidden ROI of Complaint Management

The Hidden ROI of Complaint Management

By Stephanie Ojeda|2025-03-18T09:28:08+00:00January 30th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Formal complaint management is a requirement in regulated industries such as med [...]

17 01, 2024

9 Strategies for Effective Internal Audits
9 Strategies for Effective Internal Audits

9 Strategies for Effective Internal Audits

By Stephanie Ojeda|2025-03-18T09:28:40+00:00January 17th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

As the age-old saying goes, sunlight is the best disinfectant. In the field of q [...]

17 08, 2023

Aligning Incident Management with ISO 45001 Requirements
Aligning Incident Management with ISO 45001 Requirements

Aligning Incident Management with ISO 45001 Requirements

By Stephanie Ojeda|2025-03-18T09:29:45+00:00August 17th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2 [...]

8 08, 2023

EHS Incident Management and Root Cause Analysis
EHS Incident Management and Root Cause Analysis

EHS Incident Management and Root Cause Analysis

By Stephanie Ojeda|2023-08-08T16:57:29+00:00August 8th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

Workplace safety incidents are a key driver of risk in manufacturing organizatio [...]

26 07, 2023

Risk Management in ISO 13485
Risk Management in ISO 13485

Risk Management in ISO 13485

By Stephanie Ojeda|2024-06-03T14:04:45+00:00July 26th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management, Risk Management|

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]

12 07, 2023

SOP in QMS
SOP in QMS

SOP in QMS

By Stephanie Ojeda|2025-03-18T09:37:38+00:00July 12th, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management|

Mistakes around standard operating procedure (SOP) management are widespread an [...]