Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

FDA States Clear cGMP Expectations for Combination Products
FDA States Clear cGMP Expectations for Combination Products

FDA States Clear cGMP Expectations for Combination Products

AssurX Blog2017-03-28T08:51:56+00:00March 28th, 2017|

The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]

Avoid QMS Automation Failures with the Right Implementation Team
Avoid QMS Automation Failures with the Right Implementation Team

Avoid QMS Automation Failures with the Right Implementation Team

AssurX Blog2024-07-01T22:30:41+00:00March 20th, 2017|

Even after decades of eQMS availability, a staggering number of projects still s [...]

Cybersecurity Management Expectations Clarified By FDA
Cybersecurity Management Expectations Clarified By FDA

Cybersecurity Management Expectations Clarified By FDA

AssurX Blog2017-03-14T11:01:57+00:00March 14th, 2017|

The FDA has made it abundantly clear that it expects medical device manufacturer [...]

Increased QMS Compliance Inspections For International Life Science Manufacturers
Increased QMS Compliance Inspections For International Life Science Manufacturers

Increased QMS Compliance Inspections For International Life Science Manufacturers

AssurX Blog2024-03-26T20:22:07+00:00March 6th, 2017|

International QMS compliance inspections of pharmaceutical and medical device ma [...]

Document Management + CGMP Compliance
Document Management + CGMP Compliance

Document Management + CGMP Compliance

AssurX Blog2024-06-03T13:48:07+00:00February 20th, 2017|

Data integrity within your document management process is a critical component o [...]

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 + 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.