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.
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self [...]
Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]
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.
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.
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.
Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD [...]
Medical device warning letters and domestic inspections continue to show a slow [...]
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf [...]
Our latest round of warning letters emphasize the importance for medical device [...]
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