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DOCU Whitepapers

Understanding The EU Medical Device Regulation For Device Companies

DOCU Whitepapers - Thu, 22/08/2019 - 3:01am

Europe's new Medical Device Regulation (MDR) will have a big impact on product-development timelines. Companies must be planning now for stricter biocompatibility testing requirements, which will go into effect in May 2020. This white paper, Understanding the EU Medical Device Regulation for Device Com

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Success Story - Rapid Design to Commercial Manufacturing of a Specialty Balloon Catheter

DOCU Whitepapers - Thu, 22/08/2019 - 3:01am
Learn how Freudenberg Medical took a specialty balloon catheter from design concept to market-ready product in just 18 months, rapidly bringing the customer to market and helping them establish a commanding market position.
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The Right SAP Solution for Your Midsized Company

DOCU Whitepapers - Tue, 20/08/2019 - 3:01am
Trying to understand SAP and their product line can be a bit like trying to learn a new language. This eBook compares and contrasts SAP's three ERP product offerings for small and mid-sized businesses – SAP Business One, SAP Business byDesign and SAP S/4 HANA in the public cloud. You'll find an objective appr
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Addressing the Challenges of Medium Volume Medical Box Build

DOCU Whitepapers - Mon, 19/08/2019 - 3:01am
Medical device manufacturers face two significant challenges when outsourcing. Their products must meet the requirements of a complex regulatory environment and the pressure to reduce cost continues to grow. The complex regulatory environment limits product redesign for cost reduction options and increases da
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Selecting & Justifying Sample Sizes: Where to Begin?

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
Within our industry, we have seen several approaches to selecting samples sizes; this paper will not cover all of the approaches, but it is a guide to give medical device manufacturers and pharmaceutical companies a good starting point for determining their own ideal sample size.
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Choosing Colorants for Medical Devices

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
Colorants are often added to the substrates and material components of medical devices with the primary intent of improving the usability of the devices. For instance, color coding can assist users in matching devices or sizes together when multiple options are available. Colorants can also be used to brand m
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EO Residue Levels in Medical Devices

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and many products that are not compat¬ible with other sterilizati
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Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now and What May Be on the Horizon

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am

The goal for medical device manufacturers that use EO sterilization to minimize patient exposure to EO residues and (and EO derivatives) from their devices and ensure that the levels of residual EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) pose the least amount of risk possible to the patient

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Considerations for Third-Party Reprocessing of Single-Use Medical Devices

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and steriliza
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A "Particle" of Prevention Is Worth a Pound of Cure

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices
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Sterilization & Biocompatibility of 3D-Printed Orthopedic Devices

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiven
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3D Printed Medical Devices and Biocompatibility

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am

The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and morphologies available pr

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Establishing Bioburden Alert and Action Levels

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am

Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom go any furth

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Could Lean Product Development Get You to Market Faster?

DOCU Whitepapers - Wed, 14/08/2019 - 3:01am

Every manufacturing engineer is familiar with The Machine That Changed the World: The Story of Lean Production. First published in 1990, this classic book was the first to detail the Toyota Production System from which the principles of Lean Production were derived. The authors predicted that Lean Producti

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Could Lean Product Development Get You to Market Faster?

DOCU Whitepapers - Tue, 13/08/2019 - 3:01am
3 Key Question to Find Out
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Innovative Medical Adhesives Simplify and Improve Fastening in Medical Devices

DOCU Whitepapers - Thu, 01/08/2019 - 3:01am

Modern adhesives offer medical device engineers a leg up with new options to simplify fastening and improve performance as medical devices and materials continue to advance. When faced with often hostile environments of human bodies and hospitals, modern, well-designed structural medical adhesive compounds

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When To Use a Fast Cure Adhesive

DOCU Whitepapers - Thu, 01/08/2019 - 3:01am

To reduce assembly costs, why not consider a fast cure adhesive? But one caveat might be to question the need for speed when selecting the appropriate adhesive for an application. In this white paper, you'll find an overview of the different types of fast cure adhesives, including one and two part epoxies,

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Catalog: Adhesives for the Medical Industry

DOCU Whitepapers - Thu, 01/08/2019 - 3:01am

For an overview of Master Bond's most popular medical grade epoxies, please browse this easy to read catalog organized by chemistry, key properties and curing schedules. From the prototype stage through the manufacturing process, each compound in this 20 page catalog is designed to meet specific applicatio

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Medtech Mergers & Acquisitions of 2018

DOCU Whitepapers - Wed, 24/07/2019 - 3:01am

Mergers and acquisitions (M&As) continued to change the landscape in the medical device and diagnostics industry in 2018. See which companies were bought, sold, or spun-off last year with our comprehensive list of 2018 medtech M&As. Information in the report includes the following:

  • Buyers
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Six Benefits of Selecting an EMS Provider with Product Design Capability

DOCU Whitepapers - Sat, 13/07/2019 - 3:01am
Product design engineering resources are shrinking at many companies. This often creates challenges for the team that remains. While a standalone product development firm or a contract engineering resource may seem the best option to address an engineering resource shortage, it can often result in a siloed ap
Categories: DOCU Whitepapers