Quality Management Solutions by AssurX

AssurX’s Quality Management solutions automate and streamline compliance processes, ensuring adherence to industry standards. Our platform provides comprehensive tools for tracking, reporting, and improving quality across your organization. Enhance efficiency and maintain high standards with seamless integration and real-time insights.

25 08, 2015

FDA Pilot Program Encourages Quarterly Malfunction Summary Filings

By AssurX Blog|2015-08-25T09:02:03+00:00August 25th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA will be taking applications starting Sept 1, 2015, looking for makers of cla [...]

17 08, 2015

US Drug Shortage Hits Patients, Pharmacies the Hardest

By AssurX Blog|2015-08-17T11:17:53+00:00August 17th, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Patrick Stone, President, TradeStoneQA The corner drug store is not currently [...]

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 [...]

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 [...]

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 [...]

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 [...]

11 03, 2015

Brookings Looks to Advance Medical Device Postmarket Surveillance System

By AssurX Blog|2025-05-19T19:10:41+00:00March 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Patients and medical device innovators will benefit if the United States is abl [...]

4 02, 2015

Training Management Best Practices for Emerging Life Science Companies
Training Management Best Practices for Emerging Life Science Companies

Training Management Best Practices for Emerging Life Science Companies

By AssurX Blog|2024-07-16T22:25:22+00:00February 4th, 2015|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

No matter how good your written policies are, or how clean a facility you operat [...]

21 01, 2015

Quality Takes Time, FDA’s CDER Reminds Drug Makers

By AssurX Blog|2023-03-06T21:03:25+00:00January 21st, 2015|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Scholars still debate how long it took to build the Great Wall of China, but it’ [...]