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 This section allows users to explore historical content, gain insights from previous discussions, and track the evolution of industry trends and AssurX’s solutions.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.

11 03, 2015

Brookings Looks to Advance Medical Device Postmarket Surveillance System

By AssurX Blog|2023-03-06T20:13:18+00:00March 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Patients and medical device innovators will benefit if the United States is able [...]

2 03, 2015

FDA Gives MDDS World a Big Break

By AssurX Blog|2023-03-08T21:39:11+00:00March 2nd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued [...]

9 02, 2015

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers
There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

By AssurX Blog|2015-02-09T09:27:05+00:00February 9th, 2015|Archives, FDA Regulated Industries, Quality Management|

Ron Shoop, SVP, National Sales Manager & Strategic Alliances, Medical Web E [...]

4 02, 2015

Training Management Best Practices for Emerging Life Science Companies
Training Management Best Practices for Emerging Life Science Companies

Training Management Best Practices for Emerging Life Science Companies

By AssurX Blog|2024-07-16T22:25:22+00:00February 4th, 2015|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

No matter how good your written policies are, or how clean a facility you operat [...]

21 01, 2015

Quality Takes Time, FDA’s CDER Reminds Drug Makers

By AssurX Blog|2023-03-06T21:03:25+00:00January 21st, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Scholars still debate how long it took to build the Great Wall of China, but it’ [...]

14 01, 2015

FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism

By Tamar June|2015-01-14T09:55:01+00:00January 14th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Cen [...]

8 01, 2015

FDA’s CDER Unveils Ambitious 2015 Wish List

By AssurX Blog|2023-03-08T22:49:45+00:00January 8th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The holidays came a little early for the folks at the Center for Drug Evaluation [...]

6 01, 2015

Are Energy and Utility Companies Ready for Risk Based Compliance?

By AssurX Blog|2024-01-13T01:54:14+00:00January 6th, 2015|Archives, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management, Risk Management|

Part 1: How the NERC Registered Entities are Preparing As we enter into the New [...]

30 12, 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

By Tamar June|2014-12-30T15:38:32+00:00December 30th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry|

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fisc [...]

19 12, 2014

FDA Update on UDI Implementation for Registered Medical Device Establishments
FDA Update on UDI Implementation for Registered Medical Device Establishments

FDA Update on UDI Implementation for Registered Medical Device Establishments

By Tamar June|2024-07-29T23:51:05+00:00December 19th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

In case you missed it, the FDA issued this update on UDI yesterday: Having passe [...]