Archives | AssurX

The “Archives” category at AssurX serves as a repository of valuable past content, providing access to a comprehensive collection of articles, insights, and updates related to quality management and compliance. This section allows users to explore historical content, gain insights from previous discussions, and track the evolution of industry trends and AssurX’s solutions. Whether you’re looking for specific information or browsing for inspiration, the archives offer a wealth of knowledge to support your quality and compliance efforts.

24 06, 2014

FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers
FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers

FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers

By AssurX Blog|2014-06-24T10:11:44+00:00June 24th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

Distilling the FDA Guidance on How to Address Inaccurate Online Claims Against M [...]

3 06, 2014

FDA Acts to Harmonize Global Adverse Event Reporting
FDA Acts to Harmonize Global Adverse Event Reporting

FDA Acts to Harmonize Global Adverse Event Reporting

By AssurX Blog|2014-06-03T09:28:22+00:00June 3rd, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

FDA Acts to Harmonize Global Adverse Event Reporting - It's a small world after [...]

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 [...]

20 03, 2014

Medical Device Industry Endures Tough 2013; 2014 Prospects Not Much Better

By AssurX Blog|2014-03-20T10:38:30+00:00March 20th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

It's March, but you could forgive medical device industry leaders if they're sti [...]

17 03, 2014

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

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

By AssurX Blog|2014-03-17T14:29:27+00:00March 17th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Jeff Mazik, Vice President, Life Science Solutions, AssurX Companies in the Ph [...]

10 03, 2014

FERC Order to Impose Stricter Physical Security Standards on Electric Utilities

By AssurX Blog|2014-03-10T08:13:23+00:00March 10th, 2014|Archives, NERC Compliance, Regulatory Compliance Management, Risk Management|

On March 7th, FERC released a new order (Docket No. RD14-6-000) directing the No [...]

19 02, 2014

CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate

By Tamar June|2023-03-08T22:39:49+00:00February 19th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The Center for Devices and Radiological Health or CDRH will focus on encouraging [...]

18 02, 2014

NERC and Industry Move in the Right Direction for Greater Reliability
NERC and Industry Move in the Right Direction for Greater Reliability

NERC and Industry Move in the Right Direction for Greater Reliability

By AssurX Blog|2024-01-13T01:45:44+00:00February 18th, 2014|Archives, NERC Compliance, Regulatory Compliance Management, Risk Management|

There is a different feel out there in the NERC world, the Electric Reliability [...]