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DOCU Whitepapers

The Value of ISO 13485 in a Design Centric, Medical Product Development Firm

DOCU Whitepapers - Tue, 31/03/2020 - 3:01am
This article explores the value that ISO 13485 Certification brings to both the medical design and development firms that maintain certification and to the clients that benefit from them. Common misconceptions about a Certified QMS include that it adds expense to the project and that it is
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Five Areas to Audit when Utilizing a Low Cost Medical Contract Manufacturer

DOCU Whitepapers - Tue, 31/03/2020 - 3:01am
Medical device manufacturers face a significant challenge in the market-driven need to reduce cost without sacrificing quality. This has driven sourcing teams to seek suppliers in lower cost labor regions. The lowest cost regions may lack suppliers with quality systems, procedures and production infrastru
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Less is More: How Lean Processes can Bolster Profits and Sustainability

DOCU Whitepapers - Wed, 25/03/2020 - 4:01am
Medical device manufacturers are just like every other business regarding their desire to maximize profits and sustainability by reducing waste and losses. However, unlike most businesses, medical device manufacturers don't use specific, proven methodologies to achieve these goals.
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Going (Well) Beyond Product Safety Standards

DOCU Whitepapers - Wed, 25/03/2020 - 4:01am
Medical manufacturer GCX outlines safety tests that every hospital or medical device manufacturer should conduct before a solution is put into production.
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Endocrine Disruptors in Medical Devices: An Integrated Approach for Compliance with Regulatory Requirements

DOCU Whitepapers - Wed, 18/03/2020 - 4:01am
The goal of the present paper is to propose a systematic, standard workflow for the safety assessment of endocrine disruptors through the understanding of what EDCs are, where they are found and how to mitigate their exposure via the performance of the biological evaluation of MDs, followed by the evaluat
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Calculations & Formulas for Brush DC Motors

DOCU Whitepapers - Mon, 16/03/2020 - 4:01am
When selecting a brush DC motor for an application or developing a powered prototype, there are several basic motor physics principles which must be considered to produce a safe, well-functioning, sufficiently-powered precision drive system. This guide includes important methods, formulas & calculation detail
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How to Select a DC Motor: Coreless and Iron Core Brushed DC Motors

DOCU Whitepapers - Mon, 16/03/2020 - 4:01am
Considering a coreless DC motor for your next application? Can't decide between brush and brushless? Despite their simplicity, selecting a small DC motor for an application can still be a daunting task. There are many other variables to take into account including dimensions, load, duty cycle, etc. This white
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MOTOR CALCULATIONS: for Coreless Brush DC Motors

DOCU Whitepapers - Mon, 16/03/2020 - 4:01am
An empirical and theoretical approach
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Building the Engineering Team You Need

DOCU Whitepapers - Thu, 12/03/2020 - 4:01am
Finding the right resources to meet your company's engineering needs can be challenging. In this white paper, Kent Kallsen, Vice President of Engineering at Delve, outlines the various types of work that engineers perform and how to effectively hire internal staff and team-source contract resources to keep pr
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Case Study: DC Dexcom

DOCU Whitepapers - Thu, 12/03/2020 - 4:01am

Dexcom is a leader in continuous glucose monitoring (CGM) systems for people with Type 1 and 2 diabetes. Rather than the “snapshot in time” reading that a traditional glucose meter provides, CGM continuously tracks glucose levels so that users can see trends and patterns to help better manage their diabe

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The Role of Virtual Prototyping in Product Development

DOCU Whitepapers - Thu, 12/03/2020 - 4:01am
When performed at the right stages of medical device development, virtual prototyping can provide certainty that speeds up the process. This white paper looks at the three stages of product development and the role of virtual prototyping including useful tools for each phase.
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Surgical Robotics: The Market Landscape Today and Tomorrow

DOCU Whitepapers - Wed, 04/03/2020 - 3:01am
A look back at the history of robotic-assisted surgery offers a glimpse into the future of surgical robots.
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The Tooling Equation: Are You Maximizing Value?

DOCU Whitepapers - Sun, 01/03/2020 - 3:01am
Tooling for molded parts is often an area that many medical device manufacturing sourcing teams see simply as a line item in non-recurring engineering costs. However, anticipated project volumes, complexity of tool, tooling vendor selection and tool maintenance strategy are all issues that can impact prod
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IP Protection: Four Areas to Audit in Selecting A Contract Manufacturer

DOCU Whitepapers - Sun, 01/03/2020 - 3:01am

Intellectual property (IP) is the core of competitive advantage. When products are outsourced, the contract manufacturer performing the final assembly typically has access to the complete documentation package for the products they build. Where are the checks and balances? How can be certain your c

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Outsourcing in Mexico: Is This Location the Best Fit for Your Project?

DOCU Whitepapers - Fri, 28/02/2020 - 3:01am

The last few years have challenged every supply chain manager's ability to craft a successful outsourcing strategy as perceived advantages have shifted due to tariffs, changes in tax policies, new trade agreements and unanticipated supply chain disruptions.

There are some universal truths releva

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Finding the Optimal Metal Tubing for Medical and Critical Applications

DOCU Whitepapers - Fri, 28/02/2020 - 3:01am
Selecting the best alloy for a tubing application can be a daunting task considering the wide variety of stainless steel and metal alloys available. The chromium in stainless steel forms a coherent passive oxide film and oxygen barrier, which imparts corrosion resistance. All stainless steels contain at least
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Top 100 Medical Device Companies of 2019

DOCU Whitepapers - Thu, 20/02/2020 - 3:01am

See which companies lead the pack in the medtech industry with our free 2019 ranking of the top 100 public medical device and diagnostics companies by sales. Information in the report includes the following:

  • Company name
  • Exchange ticker
  • Exchange
  • 2019 revenue
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Simulation of Radiation Sterilization: Selection and Optimization of the Right Source

DOCU Whitepapers - Wed, 19/02/2020 - 3:01am
When using radiation sterilization, medical device and pharmaceutical companies are faced with the choiceof gamma, electron-beam, or x-ray sources. But which one to choose? While it may be tempting to go withthe familiar option, each of these techniques has its own benefits that might make it the ideal choice
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Simulation of Radiation Sterilization: Guiding Product Design

DOCU Whitepapers - Wed, 19/02/2020 - 3:01am
In a typical product design process, testing to ensure that the sterilization regulations are met is only performed after the product has been fully designed, built, tested, and readied for mass production. There is an inherent risk to this approach: a great deal of effort and resources have been invested in
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Simulation of Radiation Sterilization: Choosing the Best Packing Configuration

DOCU Whitepapers - Wed, 19/02/2020 - 3:01am
For cost reduction, it is beneficial to choose a packing configuration that allows for the highest throughput. Typically, the ideal arrangement is found through experimental trial-and-error. In addition to being expensive and time-consuming, such an approach might miss the packing configuration that finds the
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