When a medical device batch is rejected, the cost is staggering. A single rejection can wipe out $600K-$2M in logistics, rework, and re-sterilization costs. But the real damage goes far beyond mere dollars. Quality misses can cause strained Original Equipment Manufacturers (OEMs) and Contract Manufacturers (CMs) relationships, delay launches, and even FDA scrutiny that can […]
The FDA classifies medical devices based on risk to patients, with Class I being the lowest and Class III the highest. Class II and Class III devices — such as infusion pumps, orthopedic implants, or cardiovascular catheters — carry greater patient risk, requiring more stringent design, testing, and postmarket controls. These higher classifications trigger more […]
Manufacturing has become faster, more precise, and increasingly automated – but that hasn’t made it immune to defects. In fact, the complexity of today’s production environments has introduced a new challenge: the tiniest deviation in process, machine behavior, or raw material consistency can snowball into full-blown quality failures. And by the time those failures are […]
In modern manufacturing, not all defects are created equal – but they are often treated as if they are. A minor blemish on a surface finish might be completely inconsequential to a product’s function or safety, yet it could still trigger batch rejections, customer complaints, or costly rework. On the other hand, a seemingly trivial […]
Discover how transparent quality protocols reduce friction between OEMs and contract manufacturers, ensuring efficiency, trust, and better product outcomes.
In medical device manufacturing, quality isn’t just a benchmark — it’s a life-critical standard. Medical devices, particularly surgical and implantable devices, demand near-zero defect tolerance. Even the smallest flaw can trigger downstream consequences: from failed procedures and hospital brand-switching to FDA oversight that can last months. Yet, despite stringent quality control processes, batch rejections still […]
In today’s competitive manufacturing landscape, the debate around manual vs. automated inspection is more relevant than ever. While many production lines have adopted inline inspection automation, manual quality control still plays a central role—though not without its limitations. Manual inspection, or manual quality control, is used by dozens of industries, from medical device manufacturers to […]
Introduction In the world of computer vision and object detection, precision is key. Whether it’s for quality control in manufacturing, autonomous driving, or medical imaging, detecting objects accurately is the first step in automating real-world processes. But sometimes, the detection system might produce redundant or overlapping bounding boxes for the same object. This is where […]
Medical devices must meet the highest quality standards to meet patient safety concerns. This means devices must be effective, defect-free, and minimize patient harm. For manufacturers, medical devices must also display consistency and conformity in performance and manufacturing while meeting current regulatory compliance. With AI-driven automated inspection tools, all of this becomes possible, thanks to […]
Introduction Object detection has become a cornerstone in computer vision, enabling machines to not only identify what’s in an image but also where it is. From autonomous driving to manufacturing quality control, object detection is transforming industries. However, training robust object detection models can be a complex and time-consuming task. That’s where Akridata comes in. […]