Category Archives: Quality Systems

Five Strategies for Effective Supplier Management

Medical device manufacturers commonly use outsourced suppliers for device components, assembly, packaging, labeling, and sterilization. An outsourced supplier may even produce the entire finished device under the manufacturer’s brand name. In all of these instances, it is ultimately the manufacturer’s (specification developer’s) responsibility, not the outsourced supplier, to ensure that the devices meet all specifications. To meet this responsibility,…
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Human Factors: Integrating the Human Condition into Medical Device Design

Human factors and usability engineering are synonymous terms which describe the application of knowledge about human behavior toward the design of a device. Understanding that human behavior can easily result in adverse events with medical devices, the FDA recently issued the guidance document, Applying Human Factors and Usability Engineering to Medical Devices, to provide recommendations…
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FDA Inspection Trends: A More Collaborative Environment

QA Consulting has identified a shift in perception within the medical device industry regarding FDA inspections in recent years.  Specifically, manufacturers find that the agency’s investigators are fairer in their inspections and more tolerant of gaps when manufacturers demonstrate a proactive commitment to compliance and are actively working to remediate any gaps. The FDA’s data…
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