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.

16 12, 2016

Risk Management + Adverse Event Reporting: FDA Guidance
Risk Management + Adverse Event Reporting: FDA Guidance

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX Blog|2016-12-16T10:21:33+00:00December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Risk management and adverse event reporting protocols for medical device manufac [...]

14 12, 2016

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

By AssurX Blog|2016-12-14T15:08:22+00:00December 14th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance Management, Risk Management|

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.

8 11, 2016

Weak CAPA Programs Hit Globally by FDA Warnings
Weak CAPA Programs Hit Globally by FDA Warnings

Weak CAPA Programs Hit Globally by FDA Warnings

By AssurX Blog|2016-11-08T14:40:29+00:00November 8th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.

31 10, 2016

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

By AssurX Blog|2023-03-08T22:42:36+00:00October 31st, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.