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.

6 02, 2025

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

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

By AssurX Blog|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 [...]

28 01, 2025

Implementing Global Data Privacy Compliance Plans
Implementing Global Data Privacy Compliance Plans

Implementing Global Data Privacy Compliance Plans

By Paul Fricke|2025-04-04T02:25:00+00:00January 28th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

As businesses continue to embrace digital transformation, cloud computing has e [...]

23 01, 2025

Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing
Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing

Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing

By Stephanie Ojeda|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
How to Achieve Manufacturing Quality Compliance Success: Apply Automation

How to Achieve Manufacturing Quality Compliance Success: Apply Automation

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

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

By Gokul Dharani|2025-10-03T03:40:38+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 [...]

12 12, 2024

Using Your QMS to Support cGMP Compliance
Using Your QMS to Support cGMP Compliance

Using Your QMS to Support cGMP Compliance

By Stephanie Ojeda|2025-03-18T09:13:16+00:00December 12th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In FY 2023, the majority of warning letters issued to pharmaceutical manufactur [...]

5 12, 2024

AI in Medical Device Manufacturing: How It’s Transforming an Industry
AI in Medical Device Manufacturing: How It’s Transforming an Industry

AI in Medical Device Manufacturing: How It’s Transforming an Industry

By Stephanie Ojeda|2025-04-04T01:31:15+00:00December 5th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]

21 11, 2024

FDA Inspection Expectations in 2025
FDA Inspection Expectations in 2025

FDA Inspection Expectations in 2025

By Stephanie Ojeda|2025-04-04T02:22:07+00:00November 21st, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]

14 11, 2024

Critical Aspects of Quality Management Systems: Focusing on the Validation Process
Critical Aspects of Quality Management Systems: Focusing on the Validation Process

Critical Aspects of Quality Management Systems: Focusing on the Validation Process

By Victoria Alestra|2025-10-03T03:36:11+00:00November 14th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In regulated industries like pharmaceuticals, medical devices, and food manufac [...]

30 10, 2024

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

By Stephanie Ojeda|2025-04-04T02:28:32+00:00October 30th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]