DOCU Whitepapers

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.

In thi

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

Enhance Product Lifecycle and Profits with a Proactive Approach

Are you taking the steps to avoid manufacturing efficiencies? Read our white paper to learn how a Design for Manufacturing approach with a contract manufacturer can help you mitigate risks while streamlining your manufacturing processes.