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 This section enables users to explore historical content and gain insights from previous discussions.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

19 06, 2015

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

By Tamar June|2025-10-02T22:27:08+00:00June 19th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Looks like it's crunch time for medical device manufacturers. Whether they subm [...]

18 06, 2015

FDA’s Shuren Works to Assure Device Industry Innovators

By AssurX Blog|2015-06-18T08:46:37+00:00June 18th, 2015|Archives, FDA Regulated Industries, Medical Device Industry|

Calling it something of a “culture change” at the Center for Devices and Radiolo [...]

10 06, 2015

FDA Moves UDI Initiative Further Down the Production Line

By AssurX Blog|2015-06-10T10:04:49+00:00June 10th, 2015|Archives, Medical Device Industry, Quality Management, Regulatory Compliance Management|

We, and others, like to take the FDA to task for missing deadlines or behaving i [...]

4 06, 2015

Large Utilities Power Up with AssurX Enterprise GRC Solution

By Tamar June|2025-10-02T22:51:33+00:00June 4th, 2015|Archives, NERC Compliance, Regulatory Compliance Management, Risk Management|

Increasingly complicated, and disparate, regulatory requirements and a demand fo [...]

28 05, 2015

Big Pharma Goes Big for Big Data

By AssurX Blog|2015-05-28T09:54:14+00:00May 28th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry|

When it comes to data, big pharma knows what big pharma likes, according to a ne [...]

20 05, 2015

Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation

By AssurX Blog|2023-03-08T22:51:05+00:00May 20th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Just when we'd all decided Washington lawmakers couldn't do much more than enjoy [...]

11 05, 2015

Should FDA Get Tougher on IRBs?

By AssurX Blog|2015-05-11T08:06:28+00:00May 11th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance Management|

Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Revi [...]

30 04, 2015

Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls

By AssurX Blog|2024-06-03T13:21:35+00:00April 30th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Risk Management|

IEC 62304, the international standard that defines software development lifecycl [...]

28 04, 2015

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR

By Tamar June|2015-04-28T07:14:17+00:00April 28th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]

23 04, 2015

FDA’s Action Plan Demands Some Industry Action, Too

By AssurX Blog|2015-04-23T08:10:42+00:00April 23rd, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed [...]