AssurX Blog
Straight talk for regulated industries.
AI in Medical Device Manufacturing: How It’s Transforming an Industry
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first AI-powered diagnostic system, a software program used to detect diabetes-related vision loss. Since then, [...]
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspections of regulated manufacturers’ facilities to identify and address quality system failures. With a high [...]
Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated Quality Management System (QMS) is [...]
How Compliance Software Can Help Manage CIP 007: Strengthening Critical Infrastructure Security
In today’s interconnected digital landscape, ensuring the security and integrity of critical infrastructure systems is more important than ever. The Critical Infrastructure Protection [...]
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rule harmonizing its Quality System Regulation (QSR) with ISO 13485 for medical device quality management. [...]
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with levels of engine oil, windshield wiper fluid, and coolant. By doing so, you can avoid some of the most comm [...]
