Quality Management Solutions by AssurX

AssurX’s Quality Management solutions automate and streamline compliance processes, ensuring adherence to industry standards. Our platform provides comprehensive tools for tracking, reporting, and improving quality across your organization. Enhance efficiency and maintain high standards with seamless integration and real-time insights.

3 12, 2014

FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies

By Tamar June|2014-12-03T10:19:41+00:00December 3rd, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality S [...]

25 11, 2014

FDA FastStats: A Look Back at 2013 Medical Device 483 Observations

By Tamar June|2014-11-25T10:40:05+00:00November 25th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approa [...]

24 11, 2014

FDA’s Local Offices Flex Regulatory Muscle

By AssurX Blog|2014-11-24T11:01:23+00:00November 24th, 2014|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In our latest round-up, it was the District Offices turn to chime in on medical [...]

21 11, 2014

Are You Ready for 21st Century eMDR Submissions?
Are You Ready for 21st Century eMDR Submissions?

Are You Ready for 21st Century eMDR Submissions?

By AssurX Blog|2014-11-21T10:35:19+00:00November 21st, 2014|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]

13 08, 2014

FDA Guidance Advises Device Makers to Think About Home-Use

By AssurX Blog|2023-03-08T22:51:31+00:00August 13th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Medical device manufacturers would be well-advised to address any potential home [...]

5 08, 2014

FDA Spreads Regulatory Love Nationwide

By AssurX Blog|2023-03-08T22:52:50+00:00August 5th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Detroit may be struggling with bankruptcy, but in a flurry of activity that woul [...]

14 07, 2014

FDA Lets MDDS Off The Regulatory Hook

By AssurX Blog|2014-07-14T11:59:28+00:00July 14th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA won't enforce compliance with regulatory controls that apply to medical imag [...]

20 05, 2014

Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer

By AssurX Blog|2023-03-14T22:48:07+00:00May 20th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

This latest round of medical device warning letters is all about pushback. The F [...]

14 04, 2014

The Six C’s of Document Management Best Practices for Life Sciences

By AssurX Blog|2024-06-03T13:45:50+00:00April 14th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Implementing a best-practice solution for any quality process is essential to he [...]

25 03, 2014

Partnership of Productivity Tools Will Allow You to Focus More on Creating Quality Products

By AssurX Blog|2023-10-18T21:13:09+00:00March 25th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Risk Management|

Dennis Payton, Vice President of Product Marketing and Development, Expandable [...]