Quality Management

The “Quality Management” category at AssurX provides a comprehensive look into effective strategies and tools for optimizing quality processes. This section covers essential topics such as process improvement, compliance integration, and performance measurement. By leveraging these resources, organizations can enhance their quality management systems, ensuring consistent product quality and operational efficiency. AssurX offers the expertise and solutions necessary to drive continuous improvement and maintain high standards across industries.

Risk Management Best Practices for Cybersecurity Compliance
Risk Management Best Practices for Cybersecurity Compliance

Risk Management Best Practices for Cybersecurity Compliance

AssurX Blog2017-01-30T01:59:17+00:00January 30th, 2017|

A new FDA guidance concerning risk management helps medical device manufacturers [...]

Tougher Quality Management Enforcement By FDA In 2017
Tougher Quality Management Enforcement By FDA In 2017

Tougher Quality Management Enforcement By FDA In 2017

AssurX Blog2017-01-23T10:06:32+00:00January 23rd, 2017|

Quality management, always an FDA focus during inspections, could become even mo [...]

Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk Management + Quality Metrics Reporting: Revised FDA Guidance

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

AssurX Blog2017-01-16T12:48:28+00:00January 16th, 2017|

Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]

Part I: Enterprise Quality Management System Selection Best Practices

AssurX Blog2016-12-31T09:58:14+00:00December 31st, 2016|

Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]

Document Management Problems Threaten Pharmaceutical Manufacturers
Document Management Problems Threaten Pharmaceutical Manufacturers

Document Management Problems Threaten Pharmaceutical Manufacturers

AssurX Blog2016-12-19T17:33:07+00:00December 19th, 2016|

Document management problems could soon impact the momentum in the number and sp [...]

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

Risk Management + Adverse Event Reporting: FDA Guidance

AssurX Blog2016-12-16T10:21:33+00:00December 16th, 2016|

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

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

Weak CAPA Programs Hit Globally by FDA Warnings

AssurX Blog2016-11-08T14:40:29+00:00November 8th, 2016|

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.

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?

AssurX Blog2025-10-02T21:52:01+00:00October 31st, 2016|

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.

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card
What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

AssurX Blog2023-02-27T20:08:48+00:00October 24th, 2016|

If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.

How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations
How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations

How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations

AssurX Blog2025-04-04T02:24:31+00:00October 14th, 2016|

It's time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management (QMS) processes - especially document management and change control - will be critical to comply with such a disparate group of regulations working with so many regulatory bodies.