AssurX Archives: Historical Insights on Compliance

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 This section enables users to explore historical content and gain insights from previous discussions.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.

15 10, 2014

FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!

By AssurX Blog|2014-10-15T09:40:01+00:00October 15th, 2014|Archives, eMDR, FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

After a flurry of activity, it's been relatively quiet of late on the FDA warnin [...]

1 10, 2014

Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright

By AssurX Blog|2014-10-01T08:08:26+00:00October 1st, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

Well, Halloween is approaching boys and girls. And while it's fun to don a Dracu [...]

24 09, 2014

FDA Proposals Take a Fresh Look at Some Stale Food Issues

By Tamar June|2024-06-25T18:27:54+00:00September 24th, 2014|Archives, FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

That landmark Food Safety Modernization Act (FSMA) just keeps getting more and m [...]

17 09, 2014

The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See

By Tamar June|2014-09-17T13:49:20+00:00September 17th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

In a previous post we looked at the FDA's relatively ho-hum guidance on social m [...]

15 09, 2014

It’s Time to ‘Get’ IEC Before It ‘Gets’ You

By AssurX Blog|2023-03-06T18:30:42+00:00September 15th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

FDA medical device recalls are on the rise. An increasingly active FDA, coupled [...]

26 08, 2014

FDA IDE Guidance Offers Industry Important Clarity

By AssurX Blog|2025-10-02T22:23:41+00:00August 26th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Inv [...]

18 08, 2014

Cybersecurity & Reliability Assurance Initiatives Top Priority at NERC Board Meetings

By AssurX Blog|2025-05-19T19:21:26+00:00August 18th, 2014|Archives, NERC Compliance, Regulatory Compliance Management, Risk Management|

NERC held its Board of Trustees (BOT) and Member Representatives Committee (MRC) [...]

13 08, 2014

FDA Guidance Advises Device Makers to Think About Home-Use

By AssurX Blog|2025-10-02T22:12:37+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 risk [...]

5 08, 2014

FDA Spreads Regulatory Love Nationwide

By AssurX Blog|2025-10-02T22:07:41+00:00August 5th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

29 07, 2014

Time to Take a Closer Look at FDA MDDS Moves

By AssurX Blog|2023-03-06T18:32:43+00:00July 29th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

The FDA recently released a new draft guidance document for Medical Device Data [...]