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DOCU Whitepapers

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Qmed Directory Latest Whitepapers.
Updated: 1 hour 32 min ago

Selecting & Justifying Sample Sizes: Where to Begin?

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.
Categories: DOCU Whitepapers

Choosing Colorants for Medical Devices

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
Categories: DOCU Whitepapers

EO Residue Levels in Medical Devices

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
Categories: DOCU Whitepapers

Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now and What May Be on the Horizon

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

Categories: DOCU Whitepapers

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

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
Categories: DOCU Whitepapers

A "Particle" of Prevention Is Worth a Pound of Cure

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

Sterilization & Biocompatibility of 3D-Printed Orthopedic Devices

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
Categories: DOCU Whitepapers

3D Printed Medical Devices and Biocompatibility

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

Categories: DOCU Whitepapers

Establishing Bioburden Alert and Action Levels

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

Categories: DOCU Whitepapers

Could Lean Product Development Get You to Market Faster?

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

Categories: DOCU Whitepapers

Could Lean Product Development Get You to Market Faster?

Tue, 13/08/2019 - 3:01am
3 Key Question to Find Out
Categories: DOCU Whitepapers

Innovative Medical Adhesives Simplify and Improve Fastening in Medical Devices

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

Categories: DOCU Whitepapers

When To Use a Fast Cure Adhesive

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,

Categories: DOCU Whitepapers

Catalog: Adhesives for the Medical Industry

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

Categories: DOCU Whitepapers

Medtech Mergers & Acquisitions of 2018

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
Categories: DOCU Whitepapers

Six Benefits of Selecting an EMS Provider with Product Design Capability

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

The Clock Is Ticking: Will Notified Body Capacity for the EU MDR Affect You?

Tue, 09/07/2019 - 3:01am
We are less than one year away from the full implementation of the European Union Medical Device Regulation (MDR) (May 2020) and three years away from the full implementation of the In Vitro Device Regulation (IVDR) (May 2022).
Categories: DOCU Whitepapers

Actionable Steps to Eliminate Small-Bore Connector Misconnection

Tue, 09/07/2019 - 3:01am
Adopting ISO 80369
Categories: DOCU Whitepapers

Advancements in Clear High Barrier Packaging Materials

Tue, 02/07/2019 - 3:01am

Clear high-barrier materials are an excellent alternative to traditional aluminum foil. Manufacturers enjoy the ability to easily inspect packaged product through the use of vision systems, metal detectors, and manual visual inspection. As a marketing tool, clear materials allow for product differentiation

Categories: DOCU Whitepapers

Protecting Healthcare Software

Fri, 28/06/2019 - 3:01am

The purpose of this white paper is to highlight potential threats in typical modern medical applications in terms of cybersecurity and protection of patients' medical data, and how to effectively address these threats with Intertrust's whiteCryption® technology.

Categories: DOCU Whitepapers