Qmed Directory Latest Whitepapers.
Updated: 1 hour 3 min ago
The "sticking" or adsorption of proteins and other bio-substances onto the surfaces of diagnostic instrument components and devices is a major challenge for manufacturers in the medical industry. When these substances remain on metal surfaces, the accuracy of results and longetivity of the system is compromis
Proteins and other biomedia are prone to adsorbing onto or corroding stainless steel surfaces, leading to inaccuracies in clinical assays and detrimental downtime of the analytical instrument.
Medical-grade textiles have been proven to deliver the high degree of versatility and performance that OEMs need to create implantable devices that best meet the needs of today's surgeons – and patients. As a result, the market for medical textiles is rapidly growing.
The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the performance characteristics of the device.
There is a lot of excitement in the medical device packaging industry about pre-validated packaging. Using pre-validated packaging may reduce time to market and minimize expense related to package development and validation.
The extrusion and catheter finishing processes are inextricably linked and balancing these processes can be a complex undertaking
Plasma surface treatment is used to improve a surface's receptiveness to adhesives, inks, paints & coatings. Three distinct surface modification processes occur simultaneously when exposing a surface to plasma treatment: Cleaning, Etching & Functionalizing.
Achieving regulatory compliance is a hurdle for medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in delays, warning letters, and even business closure. Design controls are at the heart of the FDA's quality system regulation specified un
Considering the severe consequences of noncompliance, it's hard to imagine anything more important. First and foremost, the health and well-being of patients is at risk. A product intended to improve health must be safe, reliable, and accurate. From a business standpoint, noncompliance can result in costly ap
Manufacturing medical device parts and features in the micro range is not as simple as miniaturizing macro processes. New tools, equipment, processes, and technologies are rapidly emerging to meet the unique needs at the micro size. As the industry overcomes the challenges of producing ever smaller devices, t
Micro-metal injection molding (micro-MIM) is becoming a go-to process for micro metal parts. Due to technological advances, micro-
MIM has become a highly efficient method for manufacturing micro parts with tight tolerances at high volumes.
Medical device manufacturers and their supply chains must get their products to market quickly while facing new technological challenges, global competition, and the need to mitigate risks. Learn how you can compete with ever-changing regulations to deliver high-quality products to market.
Having a rock-solid approach to quality is a prerequisite for medical device success. The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the we
Viant facilitated the design and managed the production of the inner and outer tube. Viant's deep engineering and process expertise drove development to optimize critical areas of the tube to reach the extreme tolerances needed to achieve the desired performance.
The Viant team leveraged its product design experience to reverse engineer 35 components, using in-house inspection as well as laser and CT scanning to get accurate 3D geometry.
In our last FDA Update, we implied that FDA policy can change on a “dime” and that policy is basically controlled by Congress. As result of the November 6 National Election results, there is a major shift in the control of Congress.
Medical device manufacturers must establish quality systems to comply with FDA regulations and other standards like ISO 13485. A single, unified quality management system (QMS) to manage documents, SOPs, training records, and quality processes in context with the entire product record increases visibility and
Who says a soft, flexible, liquid tight medical bag with
shapes and fitments must be made of PVC? Actually,
many packaging experts out there today will tell you
that. The truth is, it's outdated thinking. With the
right handling capabilities and expertise, polyolefins
can deliver all the performance
An established maker of
multi-axis stages was seeking
smooth, quiet, long-lasting
performance from its linear
motion technology. The
company's engineers decided
to perform a comprehensive
test on identical stages
between a regular ball screw
from a large OEM and new
optiSLITE ball screws