Regulatory Compliance Management

The “Regulatory Compliance Management” category at AssurX is dedicated to helping organizations navigate the complex landscape of regulatory requirements. This section provides practical tools and expert insights to ensure adherence to industry standards and regulations. It covers a range of topics, including compliance strategy development, risk assessment, and the integration of compliance management systems. By exploring these resources, professionals can streamline their compliance processes and mitigate risks effectively. AssurX equips you with the knowledge and solutions needed to maintain compliance and drive operational excellence.

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 [...]

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|2024-07-01T22:33:15+00:00June 4th, 2015|Archives, NERC Compliance, Regulatory Compliance Management, Risk Management|

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

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 [...]