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 This section allows users to explore historical content, gain insights from previous discussions, and track the evolution of industry trends and AssurX’s solutions.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

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 [...]

6 02, 2014

Medical Device Makers Urged to Play Nicer by Sharing Data
Medical Device Makers Urged to Play Nicer by Sharing Data

Medical Device Makers Urged to Play Nicer by Sharing Data

By AssurX Blog|2014-02-06T14:55:02+00:00February 6th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

You shouldn't need Barney the giant purple dinosaur to remind you of the playgro [...]

30 01, 2014

Analysis: No Need For State of the Union Analysis

By AssurX Blog|2014-01-30T09:07:47+00:00January 30th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Those of us in and around Washington D.C. like to tell folks leading up to a pre [...]

16 01, 2014

Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative

By AssurX Blog|2014-01-16T09:57:03+00:00January 16th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

Let's start with what most everyone agrees on: The Unique Device Identification [...]

13 01, 2014

Interpreting the FDA View of Medical Device Design Controls

By AssurX Blog|2023-10-18T21:16:08+00:00January 13th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Dennis Payton, Vice President of Product Marketing and Development, Expandable [...]

7 01, 2014

FDA’s 2014 Promises Increased International Operations, Label Enforcement
FDA’s 2014 Promises Increased International Operations, Label Enforcement

FDA’s 2014 Promises Increased International Operations, Label Enforcement

By AssurX Blog|2025-05-19T19:20:30+00:00January 7th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Given the fact that the FDA probably doesn't know what it plans to do in 2014, p [...]

12 02, 2013

Part II: Next Practices for Selecting an Enterprise Quality System

By AssurX Blog|2013-02-12T10:24:03+00:00February 12th, 2013|Archives, Quality Management, Regulatory Compliance Management, Risk Management|

Note: In part one, we looked at how to approach the selection process, assess ve [...]