DOCU Whitepapers

Protein-resistant Properties of SilcoTek's Dursan Coating

DOCU Whitepapers - Thu, 13/12/2018 - 3:01am
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
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Use of Inert CVD Coating for Protein, Corrosion, and Moisture Resistance in Bioanalysis Applications

DOCU Whitepapers - Thu, 13/12/2018 - 3:01am
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.
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Choosing the Right Partner for Optimized Medical Textile Implant Manufacturing

DOCU Whitepapers - Wed, 05/12/2018 - 3:01am
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.
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Establishing Shelf Life of Medical Devices

DOCU Whitepapers - Wed, 05/12/2018 - 3:01am
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.
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How Pre-Validated Medical Device Packaging Complies with ISO Standards

DOCU Whitepapers - Wed, 05/12/2018 - 3:01am
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.
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Extrusion, a Central Process in Catheter Development

DOCU Whitepapers - Wed, 28/11/2018 - 3:01am
The extrusion and catheter finishing processes are inextricably linked and balancing these processes can be a complex undertaking
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What Plasma Does to a Surface to Improve Adhesion

DOCU Whitepapers - Thu, 22/11/2018 - 3:01am
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.
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How Strong Design Controls Simplify Compliance and Eliminate Audit Anxiety

DOCU Whitepapers - Wed, 21/11/2018 - 3:01am
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
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How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier

DOCU Whitepapers - Wed, 21/11/2018 - 3:01am
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
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How To Conquer The Challenges Of Micro-Manufacturing

DOCU Whitepapers - Wed, 21/11/2018 - 3:01am
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
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Micro-MIM Succeeds At Making Precise Micro Metal Parts

DOCU Whitepapers - Wed, 21/11/2018 - 3:01am
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.
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Meeting Regulatory Compliance in Today's Global Market

DOCU Whitepapers - Fri, 16/11/2018 - 3:01am

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.

In thi

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7 Principles of Product-Centric Quality Management

DOCU Whitepapers - Thu, 15/11/2018 - 3:01am
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
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Case Study - Advanced Energy Device Engineered with Ultra-Precise Tubing Tolerances for Superior Performance

DOCU Whitepapers - Tue, 13/11/2018 - 3:01am
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.
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Case Study - Reverse Engineering & Manufacturing Transfer Result in Cost Savings, Reduced Risk, and Increased Security

DOCU Whitepapers - Tue, 13/11/2018 - 3:01am
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.
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Can it be - The Medical Industry is Operating in Compliance?

DOCU Whitepapers - Mon, 12/11/2018 - 3:01am
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.
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Product Centric QMS: A Critical Advantage for Regulated Companies

DOCU Whitepapers - Tue, 06/11/2018 - 3:01am
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
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Design and scale shaped liquid tight bags without the risks.

DOCU Whitepapers - Tue, 06/11/2018 - 3:01am
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
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Read how an OEM customer achieved significant noise reduction using our proprietary optiSLITE ball screws.

DOCU Whitepapers - Sat, 03/11/2018 - 4:01am
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
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Consultancy vs Contract Designer

DOCU Whitepapers - Sat, 27/10/2018 - 3:01am
Categories: DOCU Whitepapers