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.

2 11, 2022

Finding the Root Cause: Where Manufacturers Go Wrong
Finding the Root Cause: Where Manufacturers Go Wrong

Finding the Root Cause: Where Manufacturers Go Wrong

By Stephanie Ojeda|2024-03-04T21:11:44+00:00November 2nd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]

12 10, 2022

5 Strategies to Improve Quality Incident Management and Root Cause Analysis
5 Strategies to Improve Quality Incident Management and Root Cause Analysis

5 Strategies to Improve Quality Incident Management and Root Cause Analysis

By Stephanie Ojeda|2024-01-13T02:20:40+00:00October 12th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]

5 10, 2022

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

By Tracy Orlick|2022-10-05T06:31:55+00:00October 5th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]

1 09, 2022

Why an EQMS is Essential for FDA Remote Regulatory Assessments
Why an EQMS is Essential for FDA Remote Regulatory Assessments

Why an EQMS is Essential for FDA Remote Regulatory Assessments

By Stephanie Ojeda|2024-01-13T01:22:12+00:00September 1st, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]

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 [...]

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 [...]

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 [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation Still Presents Challenges and Opportunities

EU Medical Device Regulation Still Presents Challenges and Opportunities

By Sal Lucido|2024-12-31T23:16:11+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation
Understanding FDA Alignment of ISO 13485 with Quality System Regulation

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By AssurX Blog|2024-03-04T21:30:05+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

31 03, 2022

miraDry Implements AssurX Quality Management and Regulatory Compliance Software
miraDry Implements AssurX Quality Management and Regulatory Compliance Software

miraDry Implements AssurX Quality Management and Regulatory Compliance Software

By Tracy Orlick|2024-01-13T02:06:41+00:00March 31st, 2022|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]