Quality Management System Solutions by AssurX

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

15 08, 2019

EU MDR Compliance: An Opportunity for Change
EU MDR Compliance: An Opportunity for Change

EU MDR Compliance: An Opportunity for Change

By AssurX Blog|2019-08-15T07:00:44+00:00August 15th, 2019|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Uncategorized|

EU MDR Compliance: The new European device regulation will bring about impactful [...]

30 07, 2019

Patch Management Policy is Not an Option
Patch Management Policy is Not an Option

Patch Management Policy is Not an Option

By Kathryn Wagner|2019-07-30T09:00:28+00:00July 30th, 2019|Energy & Utilities Industry, Regulatory Compliance Management, Risk Management|

How does a free software patch end up costing $700 million? When you don’t insta [...]

25 06, 2019

EU MDR Rules Could Impact Medical Device Business Strategies
EU MDR Rules Could Impact Medical Device Business Strategies

EU MDR Rules Could Impact Medical Device Business Strategies

By AssurX Blog|2019-06-25T09:38:18+00:00June 25th, 2019|FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Changes in the European Union (EU) MDR and IVDR standards could force business c [...]

19 06, 2019

TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes
TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes

TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes

By Tracy Orlick|2023-12-01T00:11:46+00:00June 19th, 2019|AssurX News + Success Stories, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

TEDOR expects to gain operational efficiencies for future growth using the Assur [...]

18 06, 2019

FDA to Sunset Alternative Summary Reporting (ASR) Program
FDA to Sunset Alternative Summary Reporting (ASR) Program

FDA to Sunset Alternative Summary Reporting (ASR) Program

By AssurX Blog|2023-03-08T23:16:10+00:00June 18th, 2019|eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The FDA has announced an end to the alternative summary reporting (ASR) program [...]

30 05, 2019

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest
Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

By AssurX Blog|2024-11-20T20:17:20+00:00May 30th, 2019|FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

FDA regulation 21 part 822 lays out the process, the rules, and the products th [...]

20 11, 2018

Keeping your Enterprise QMS Implementation Project on Schedule
Keeping your Enterprise QMS Implementation Project on Schedule

Keeping your Enterprise QMS Implementation Project on Schedule

By Eric Cooper|2018-11-20T15:22:28+00:00November 20th, 2018|Quality Management, Regulatory Compliance Management|

Due dates. Everyone has them, everyone wants them. Whether it’s building a house [...]

7 08, 2018

AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation
AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation

AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation

By AssurX Blog|2018-08-07T11:20:54+00:00August 7th, 2018|FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

Morgan Hill, CA – August 8, 2018 - AssurX,Inc. (AssurX), a leading provider of e [...]

24 04, 2018

Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)
Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)

Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)

By AssurX Blog|2024-07-01T22:17:54+00:00April 24th, 2018|Energy & Utilities Industry, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

AssurX, a leader in quality management software systems, will exhibit at the 201 [...]

7 02, 2018

2017 Recap: FDA Warning Letter Observations and Trends
2017 Recap: FDA Warning Letter Observations and Trends

2017 Recap: FDA Warning Letter Observations and Trends

By AssurX Blog|2024-06-25T18:32:49+00:00February 7th, 2018|Quality Management, Regulatory Compliance Management|

In 2017, the FDA released 476 warning letters. Top FDA warning letter violations [...]