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 This section allows users to explore historical content, gain insights from previous discussions, and track the evolution of industry trends and AssurX’s solutions.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

4 08, 2015

GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys

By AssurX Blog|2015-08-04T17:58:23+00:00August 4th, 2015|Archives, Medical Device Industry|

Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]

3 08, 2015

Audit Management: the Perennial EQMS Straggler

By AssurX Blog|2023-11-08T16:19:49+00:00August 3rd, 2015|Archives, Audit Management, FDA Regulated Industries, Quality Management|

AssurX has been in the business of configuring and implementing Enterprise Qual [...]

23 07, 2015

Obama Veto Threat Looms Over Medical Device Tax Battle

By AssurX Blog|2015-07-23T06:34:32+00:00July 23rd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]

20 07, 2015

FDA’s UDI Initiative Continues to Roll Forward

By AssurX Blog|2015-07-20T07:26:42+00:00July 20th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of t [...]

15 07, 2015

Will New User Fees Fuel More FDA Inspections?
Will New User Fees Fuel More FDA Inspections?

Will New User Fees Fuel More FDA Inspections?

By AssurX Blog|2015-07-15T08:25:57+00:00July 15th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

For FY 2016, FDA is requesting $4.9 billion to support our essential functions a [...]

14 07, 2015

FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures

By AssurX Blog|2023-03-08T22:53:44+00:00July 14th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

It’s been a little while since we checked the FDA’s outgoing mail tray to find o [...]

30 06, 2015

Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden

By AssurX Blog|2015-06-30T08:22:18+00:00June 30th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Crystal may be clear, but crystal balls, at least metaphorically, are certainly [...]

23 06, 2015

FDA 510(k) Approval Process Now Averages Over Six Months

By AssurX Blog|2024-12-31T23:56:42+00:00June 23rd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

If you’ve got six months – and nerves of steel – here’s some good news: You hav [...]

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|2025-05-19T19:01:30+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 [...]